Monday, April 22, 2013

Stryker Orthopaedics – ShapeMatch Cutting Guide

Recall Class: Class I

Date Recall Initiated: April 10, 2013

Product: ShapeMatch Cutting Guides

Manufacturing and Distribution Dates: May 2011 to November 2012

Product Codes and Lot Numbers: All

Use: The ShapeMatch Cutting Guides are single-use, disposable, cutting guides. They are intended to be used as surgical instrumentation to assist in the positioning of total knee replacement (arthroplasty) components intraoperatively and in guiding the marking of bone before cutting. The ShapeMatch Cutting Guides are used with the Triathlon Knee System.

Recalling Firm:
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430

Reason for Recall:
Stryker Orthopaedics has become aware of potential issues associated with internal processes for planning cases and producing ShapeMatch Cutting Guides. The parameters of the manufactured cutting guides did not meet the surgeon’s pre-operative planning parameters entered via the web application. When the parameters were manually edited to compensate for a defect in the existing software, the edits resulted in cutting guides ranges that are not cleared by the FDA. Additionally, Stryker Orthopaedics determined that another software defect resulted in the displayed parameters (e.g. depth of resection, angle of cut) not matching the cutting guides produced. This may result in serious adverse health consequences including joint instability, fracture, need for revision surgery and chronic pain and limitations of mobility.

Public Contact: Questions should be directed to Stryker at 1-888-STRYKER (787-9537) Monday through Friday from 8am - 8pm Eastern Time.

FDA District: New Jersey District Office

FDA Comments:
In November 2012, Stryker Orthopaedics e-mailed field locations, registered surgeons and imaging centers of the problem and to immediately stop prescribing, planning or performing operative or imaging procedures with the ShapeMatch Cutting Guides until further notice. In January 2013, a Product Notification was issued to all branches, agencies, surgeons and risk managers at affected hospitals informing them of the problem and risk mitigation factors.

On April 10, 2013, Stryker issued an Urgent Medical Device Recall. Stryker is recommending patients who had knee replacement surgery in which ShapeMatch Cutting Guides were used and who are experiencing symptoms to contact their surgeon. If the patient is symptom-free, they should continue to follow-up with surgeon as prescribed. This recall does not affect the Triathlon Knee System or Triathlon standard instrumentation.

The FDA has received a total of 44 reports (41 malfunctions and 3 temporary medically reversible injuries) of incidents related to the ShapeMatch Cutting Guides.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program1 either online, by regular mail or by FAX.



Wednesday, April 17, 2013

The Continuing Case of Takata’s Exploding Airbags

Last week, four Japanese automakers – Toyota, Nissan, Honda and Mazda – announced recalls of 3.4 million vehicles for “improperly pressurized” airbags made by Takata that could rupture, igniting fires or propelling metal fragments that could travel “upward toward the windshield or downward toward the front passenger’s foot well.”
They forgot to mention that they could shoot straight out and hit you in the chest, as allegedly happened in 2009 to a Florida woman who owned a 2001 Honda Civic. And, they apparently forgot to mention that these airbags have been recalled over and over again since 2001.
In this latest campaign, Takata said that it only learned of the problem in 2011, after an alleged rupture of a passenger airbag inflator occurred in Puerto Rico. Certainly, it’s unlikely that 2011 was the first the supplier heard about this issue. There have been six recalls associated with Takata airbags that explode with too much force, spraying debris in their wake. This slow-moving rolling recall for manufacturing defects involving 13-year-old vehicles raises more questions than it answers. Why is Honda identifying a manufacturing process problem so long after these vehicles were produced?
The latest recall of 2000 to 2004 vehicles suggests an age degradation issue involving the propellant. Honda’s ever-changing explanations suggest that perhaps more than one manufacturing problem lies at the root of the inflator rupture problems.  A stroll through the recall documents also reveals Honda’s odd behavior – like recalling 830,000 vehicles to find 2,400 replacement modules. The depth of NHTSA’s involvement is also unknown. The agency began asking questions in 2009, without actually assigning the recall investigation an official Recall Query number. We suspect that the Recall Management Division has been keeping close company with Honda ever since.
Honda Inflator Ruptures Through the Years
2001: Recall 01V055
In February 2001, Isuzu reported in a Defect and Noncompliance Notice that it discovered three vehicles, a 2000 and 2001 Rodeo and an MY 2001 Honda Passport had passenger side front air bag inflator modules built with too much generant.
“In the event of a crash, the abnormal amount of generant could cause the airbag to burst. Occupants could be injured either as a result of debris or as a result of crash forces not counteracted by the air bag,” Isuzu said.
According to the defect report, the undisclosed supplier told the vehicle assembly plant that it had produced air bag units with incorrectly manufactured inflators in late January 2001. At the time, Isuzu said that it only knew of three defective vehicles outside its possession – identified by Isuzu ‘s undisclosed supplier using ”radiography images in the supplier’s possession.”
So, it was a small, limited recall, since two of the vehicles were on the dealer’s lot, and only one – a Honda Passport – had been sold to a customer. 
2008: Recall 08V593
In November 2008, Honda began to recall certain 2001 Accord and Civic vehicles to replace airbags that “could produce excessive internal pressure,” causing “the inflator to rupture,” spraying metal fragments through the airbag cushion. Honda said that it learned of the problem via a June 2007 claim. In September 2008, another metal-laced deployment occurred. The limited campaign affected fewer than 4,000 vehicles.
2009: Recall 09V259
On June 30, 2009, Honda decided to expand the recall to 440,000 MY 2001 and 2002 Civic, Accord and Acura vehicles, after receiving two more claims of “unusual deployments” on May 28 and June 9.
At this point, Honda got NHTSA’s attention. In August 2009, the Recall Management Division sent Honda an information request to explain why Honda didn’t include these vehicles in the 2008 recall, and “to evaluate the timeliness of HMC’s recent defect decision.” The Recall Management Division asked for complaints, lawsuits, warranty claims and field reports, along with a lot more explanation about the “unusual deployments” and Honda investigative efforts.
In Honda’s September reply, the automaker said that its information came from Takata:
“We understood the causal factors to be related to airbag propellant due to handling of the propellant during airbag inflator module assembly.” Later, Honda and Takata pinpointed the problem to “production of the airbag propellant prior to assembly of the inflators.” Specifically, the cause was “related to the process of pressing the propellant into wafers that were later installed into the inflator modules,” and limited to “one production process” involving one high-precision compression press that was used to form the propellant into wafers, the automaker told NHTSA.
(Honda included an October 2, 2008 presentation Takata made to Honda about the causes – the substance of which was granted confidentiality.)
The automaker said that it had fielded nine complaints and one lawsuit, with the first incident reported to Honda in May of 2004. It is difficult to determine if these represented complaints apart from those mentioned in Honda’s Defect and Noncompliance reports for the 2008 and 2009 recalls, because the dates of these complaints don’t line up.
(NHTSA has fielded at least four complaints from Honda customers reporting airbag deployments that shot metal shards into an occupant. But the first such claim came in 2005. According to ODI complaint number 10152674, a driver in Wheaton, Ill. reported that during a head-on collision, “the airbag exploded and discharged metal fragments causing injury to the driver.”)
Honda said that the common thread in these complaints was over-pressurization that created “some form of separation of the metal airbag inflator shelf, resulting in metal fragments of the shell being propelled through the airbag fabric. In most cases the metal fragments were relatively small, though in one instance it appears that the second stage of the two-stage inflator became separated from the inflator module and was propelled toward the driver.”
Since NHTSA didn’t open an official Recall Query, it’s difficult to say if Honda’s submissions were sufficient to close the matter for the agency.
2010: Recall 10V041
About three months after its 2009 recall, Honda announced a third recall for 379,000 vehicles – more 2001 and 2002 Accords and Civics, and certain 2002 MY Honda CR-V, 2002 Honda Odyssey, 2003 Honda Pilot, 2002-2003 Acura 3.2TL and 2003 Acura 3.2CL vehicles. This time, Honda said that there were two different manufacturing processes used to prepare the propellant – one was verified as being within specifications, but the other was not. Honda decided to recall all of those using the second process – even though the automaker claimed that testing of some inflators from this batch found that they performed properly.
2011: Recall 11V260
In April 2011, Honda filed yet another Part 573 Defect and Noncompliance report for 2,430 replacement service part airbag modules that might have been installed in vehicles covered by previous recall expansions. Despite an analysis to determine where those 2,430 replacement modules went, Honda said they couldn’t find them – so the automaker was going to contact all owners of previously recalled models – all 833,277 of them – to capture the errant replacement modules.
The problem continued to surface. In addition to the Puerto Rico incident in 2011, in October 2012, the owner of a 2002 Civic from McKinney, Texas reported to NHTSA:
I was proceeding to make a left turn after stopping and looking at an all-way stop. A Ford truck coming the opposite direction ran the stop and crashed into my car in the right-front. The airbags deployed and I was stunned by the impact. My left ear and face were severely lacerated by fragments of the airbag inflator (which were found and photo-documented), resulting in 29 stitches and permanent scarring. Shortly after the accident, Honda sent me a recall notice regarding the airbag inflator: this was the first time I was made aware of the fact that the airbag inflator was known to produce shrapnel and had caused fatalities. Despite having owned the car since 2003 and having it serviced at dealerships several times over the years, I had not received any prior information regarding the lethal airbag defect. Honda has been irresponsible and apathetic regarding my situation and the problem in general. I could have easily been injured worse or killed by the fragments, yet the company seems to not take the problem seriously. I will absolutely never own another Honda, will forbid my family and loved ones from owning a Honda.
2013: Recall 13V132
And that brings us up to this month, when the exploding airbag recall exploded into the millions. According to Honda’s most recent Defect and Noncompliance report, the airbag that exploded in Puerto Rico in October 2011 prompted Honda to ask NHTSA if it could collect “healthy” airbag modules to see if “abnormal combustion was possible,” and guess what? It was! But Honda claims it still didn’t know why.
On February 8, NHTSA and Honda met to discuss the “ongoing investigation.” Honda said that “A recreation of propellant production using the same methods as were used during 2001-2002 production periods indicated that it was possible for propellant produced during 2001-2002 to be manufactured out of specification without the manufacturing processes correctly identifying and removing the out of specification propellant. Separately, Honda was informed by the supplier of another potential concern related to airbag inflator production that could affect the performance of these airbag modules.”
Well that clears it all up, then.
So, why are these Takata airbags spewing metal? Let’s review the explanations:
·         In 2001, it was too much generant in new vehicles.
·        In 2008, it was excessive internal pressure caused by the handling of the propellant during airbag inflator module assembly. Then it was a manufacturing process that occurred before assembling the inflators — the process of pressing the propellant into wafers, traced to one particular compression machine.
·         In 2010, Honda/Takata revealed that there were actually two different manufacturing processes used to prepare the propellant – one was verified as being within spec, but the other wasn’t.
·         In 2013, Honda/Takata discovered that the propellant produced in 2001-2002 could be out of spec without the plant knowing it, and “another potential concern” – as yet unidentified.
Confused yet? Exactly how were these propellants out of spec? Was Takata skimping on the chemical binders that hold the material together? Is this an age degradation issue – exacerbated by heat? Time? Moisture? Publicly known complaints emanate from warm climate states like Texas, Florida and Puerto Rico. If this is a manufacturing process issue, why did it take Takata six years to suss it out? Why are some newly manufactured airbags exploding and spraying shrapnel? Same reasons?
One thing is for sure: these recalls don’t inspire much confidence that the problem has been solved. 

Tuesday, April 16, 2013

Toyota, Honda, Nissan and Mazda Airbag Recalls

Japanese automakers issue airbag recall, American manufacturers may follow.

In continuing coverage of the major networks and may national medial outlets reported on the recall by Japanese automakers of over three million vehicles worldwide due to an airbag defect. Due to a supplier defect, passenger airbags can deploy too forcefully, sending shards of metal flying toward the occupants. Takata Corportation also supplies American manufacturers, so additional recalls are expected.

        ABC World News (4/11, story 5, 0:30, Sawyer, 7.43M) reported, "Tonight Toyota, Honda, Nissan and other auto makers are recalling three million vehicles worldwide, many owned by Americans. The air bags, which were made more than a decade ago by a Japanese supplier, do not inflate properly. They can send plastic or metal pieces flying into passengers." ABC notes that no injuries have been reported.

        NBC Nightly News (4/11, story 7, 0:30, Williams, 7.86M) reported, "Toyota, Nissan, Honda, Mazda all use the same manufacturer for their air bags. They all have the same defect."

        The New York Times (4/12, Jensen, Subscription Publication, 1.68M) notes that "among the automakers, Honda has had the most serious, continuing problem with air bags." The Times also reports that "the bags were produced by the Japanese supplier Takata Corporation, which also sold some of the defective products to General Motors and BMW, according to a report Takata filed Thursday with the National Highway Traffic Safety Administration in Washington. About 48,000 2003 Pontiac Vibes, which is a mechanical sibling of the Toyota Matrix, will be recalled, a G.M. spokesman, Alan Adler, wrote in an e-mail."

        The Los Angeles Times (4/11, Hirsch, 692K) reports, "The problem was reported to Japanese safety regulators late Wednesday night, but since the part manufactured by Takata Corp. is used internationally, it probably affects more automakers. 'Takata supplies a lot of U.S. manufacturers too,' said Michelle Krebs, an analyst with auto information company" The Times notes that "all of the recalled cars announced so far were produced from 2000 to 2004."

        Also reporting on the recall are Reuters (4/11), Bloomberg News (4/12, Mukai, Hagiwara), the Detroit Free Press (4/12, 280K), NPR (4/11, Glinton), USA Today (4/11, Woodyard, 1.71M), the Christian Science Monitor (4/11, Velasco, 47K), the Detroit News (4/12, Shepardson, 119K), and the Washington Times (4/12, Chumley, 76K).

Thursday, April 4, 2013

Hyundai, Kia Recall More Than 1.9M Vehicles in U.S. for Electronic Issues

Hyundai Motor Co. and Kia Motors Corp. are recalling more than 1.9 million vehicles in the United States in three recall campaigns, one of the largest ever call-backs of vehicles by the Korean automakers.
Hyundai said it is recalling 1.06 million vehicles for electronic problems after it had issued a 2009 recall for the same problem for earlier model vehicles, while Kia is recalling 623,000 vehicles to address the same problem. Hyundai said the "condition could potentially result in intermittent operation of the push-button start feature, intermittent ability to remove the vehicle's shifter from the park position, illumination of the "ESC" (Electronic Stability Control) indicator lamp in the instrument cluster, intermittent interference with operation of the cruise control feature, or intermittent operation of the stop lamps."
Since the 2009 recall, Hyundai has made three separate improvements to its stop-lamp assembly.
The new recall was prompted by an investigation by Transport Canada, the Canadian auto safety agency, which notified Hyundai in November it had nine complaints for vehicles outside of the production range of Hyundai's 2009 Canadian recall to replace the stop lamp switch. Hyundai will replace the stop lamp switch assembly "with one incorporating the most recent production refinements," but won't notify owners until June, when it expects to have enough parts on hand to complete the repairs.
The Hyundai recall covers the 2007-09 Accent, 2007-10 Elantra, 2010-2011 Genesis Coupe, 2007-11 Santa Fe, 2011 Sonata, 2007-09 Tucson and 2008-09 Veracruz. The Kia recall covers the 2007-10 Rondo, 2007 Sedona, 2011 Optima, 2007-11 Sorento, 2010-11 Soul, 2007-10 Sportage. Kia said it is not aware of any injuries connected to the problem. Kia will notify owners in May.
Hyundai and Kia operate largely as independent automakers, but share a technical center in Ann Arbor and are controlled by the same Korean firm.
Separately, Hyundai said it is recalling about 190,000 2011-13 Elantras for possible airbag problems after the National Highway Traffic Safety Administration upgraded an investigation last September. Hyundai said that during deployment of a side curtain airbag, a support bracket attached to the headliner can become displaced if the support bracket has been previously dislodged. This condition may pose a risk of injury to the vehicle occupant if contact is made between the occupant and the headliner support bracket during a side impact collision. The investigation was prompted by an injury to a driver of an Elantra from a part that dislodged during an air bag deployment that resulted in a laceration to the driver's left ear.
Hyundai found three vehicles in the United States in salvage yards with the same possible issue that were equipped with port-installed electronic "auto-dimming" rear view mirrors that are exclusive to the U.S. market.
"During the installation of the mirrors the technician could interact with the headliner in a manner that partially dislodges the bracket, allowing the side curtain airbag deployment subsequently to force the bracket to displace during the course of a collision," Hyundai said. "Further research and testing revealed that industrial manufacturing adhesive strips placed over the bracket prevent displacement of a dislodged bracket during side curtain airbag deployment."
Hyundai will install industrial manufacturing adhesive strips to the headliner to further secure the bracket to the headliner on certain 2011-13 Hyundai Elantra vehicles manufactured in Korea. Hyundai will also install industrial manufacturing adhesive strips to the service part headliner assemblies in U.S. inventory.

Wednesday, April 3, 2013

GM recalls Buick Encores because steering wheel can fall off.


The Los Angeles Times (4/2, White, 692K) reports, "General Motors is recalling some model year 2013 Buick Encores with steering wheel fasteners that may not have been properly installed. The problem could cause the steering wheel to come loose or separate from the steering column." The Times notes that "the recall involves 144 Encores equipped with a heated steering wheel and manufactured between Dec. 9 and Dec. 28." According to the Times, "GM issued a statement about the recall, saying there were no known crashes or injuries related to the problem."

        Also reporting on the recall are Reuters (4/2) and the Wall Street Journal (4/3, Welsh, 2.29M).

Subaru recalls 215,000 Outbacks, Legacies over corroded brake lines.

The New York Times (4/2, Jensen, 1.68M) reports, "Subaru is recalling at least 215,000 of its most popular models – the 2005-9 Outback wagon and Legacy sedan – because of corrosion of the brake lines, the automaker says." The Times notes that "in a report posted Tuesday on the Web site of the National Highway Traffic Safety Administration, Subaru said it had discovered that a section of the brake lines was unacceptably vulnerable to corrosion after 'seven or more winter seasons' and could eventually leak brake fluid." The recall is being conducted in states that rely heavily on road salt, including "Connecticut, Delaware, Iowa, Indiana, Massachusetts, Maryland, Maine, Minnesota, Montana, Missouri, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Vermont, Wisconsin, West Virginia and the District of Columbia."

        The AP (4/3) reports that "the problem was discovered in internal testing and no related crashes or injuries have been reported."
        Also reporting on the recall are Reuters (4/2), WUSA-TV Washington (4/3), and CNN Money (4/3).