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U.S. Department of Health and Human Services

Class 2 Device Recall LFIT COCR V40 Femoral Head; xxLong (16mm) Neck Length 26mm Diameter

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  Class 2 Device Recall LFIT COCR V40 Femoral Head; xxLong (16mm) Neck Length 26mm Diameter see related information
Date Initiated by Firm November 02, 2007
Date Posted February 07, 2008
Recall Status1 Terminated 3 on August 30, 2010
Recall Number Z-0965-2008
Recall Event ID 45902
Product Classification Semi-Constrained Metal/Polymer Cemented Hip Prosthesis - Product Code JDI
Product Stryker LFIT COCR V40 Femoral Head; xx-Long (+16mm) Neck Length 26mm Diameter Sterile, Forged Vitallium Alloy; Product Number: 6260-9-526; Howmedica Osteonics Corp. Styrker Ireland; Carrigtwohill county Cork, Ireland.
Made in Ireland.
Code Information V40 COCR LFIT HEAD 26mm/+16 -- Product Number: 6260-9-526 All Lots codes  
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Lisa Nolan
201-831-5050
Manufacturer Reason
for Recall		 Fracture of Stem Neck - The firm recently performed laboratory testing indicates that there may be a potential increased risk of stem neck fractures when a V40 +16mm offset femoral head is mated with certain Accolade TMZF femoral stems in patients classified as overweight or obese.
FDA Determined
Cause 2		 Other
Action Stryker Orthopaedics sent an Urgent Product Recall notification letters on November 9, 2007, by Federal Express with return receipt. The letter informed users of potential increased risk of stem neck fracture, when a V40 + 16mm offset femoral head is mated with certain Accolade TMZF femoral stems in patients classified as overweight or obese. The firm has asked that inventory be examined, removed and held in quarantine. A Stryker representative will contact the medical facilities to retrieve the product. If a representative has not contacted the facility to date, it is suggested that they contact Stryker at (201) 831-5972.
Quantity in Commerce 5,599 total units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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