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Limited Voluntary Recall of Stryker LFIT Anatomic Cobalt Chromium V40 Femoral Head

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The Stryker LFIT Anatomic Cobalt Chromium (CoCr) V40 femoral head had a limited voluntary recall in August, 2016, which can be viewed here.  Recalled lots included femoral heads diameter and offsets of 36+5, 40+4,  40+8, 40+12, 44+4, 44+8, and 44+12 (head diameter, neck offset). Other remaining femoral head sizes have not been recalled. One of the reported hazards noted was disassociation of the femoral head-stem and Gross Trunnion Failure (GTF). Absent from the “Urgent Medical Device Recall Notification”  is the mention of investigating or reported events of head/taper corrosion at the interface with the Titanium stem.  There are many reports of this occurring  with the FDA Maude Database.

Further, many of the clients that we represent have significant corrosion discovered at the head-neck junction of the Stryker stem.  Almost always, this is  associated with the earlier version of the Accolade Stem known as Accolade TMZF, or also commonly referred to as  Accolade 1.  Its known that the TMZF alloy is proprietary to Stryker.  Stryker  changed the Titanium alloy in a new design known as the  Accolade 2  with a standardized cross industry alloy of Titanium, but the earlier version of the TMZF Accolade is still available.  Could this be part of the problem?  It’s believed with more patients coming forward in filing claims, and  case studies investigated by revising surgeons, the truth will come out of the risk associated with failures of the use of the the Stryker LFIT Anatomic Cobalt Chromium (CoCr) V40 femoral head lots that have not been recalled, but have patients at risk for head /taper corrosion.

Given our work on previous Stryker Hip Implant Recalls, we know a lot about Stryker and their products. For this reason and others, Childers Schlueter & Smith continues to  investigate and pursue Stryker LFIT  V40 Femoral head claims associated with the Accolade TMZF stem. If you have questions about your hip implant system, please call our Stryker Hip Implant Lawyers at 1-800-641-0098 or send us a confidential message at cssfirm.com or email us at intake@cssfirm.com.

 

 

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