Date Initiated by Firm | November 02, 2007 |
Date Posted | February 07, 2008 |
Recall Status1 |
Terminated 3 on August 30, 2010 |
Recall Number | Z-0962-2008 |
Recall Event ID |
45902 |
510(K)Number | K010757 |
Product Classification |
Semi-Constrained Metal/Polymer Cemented Hip Prosthesis - Product Code JDI
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Product | Stryker COCR V40 Femoral Head; xx-Long (+16mm) Neck Length, 26mm Diameter ; Sterile, Forged Vitallium Alloy, Product Number: 6260-5-526; Howmedica Osteonics Corp. Styrker Ireland; Carrigtwohill county Cork, Ireland. Made in Ireland. |
Code Information |
V40 COCR HEAD 26mm/+16 -- Product Number: 6260-5-526 All lot codes. |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2002
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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 |
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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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510(K) Database | 510(K)s with Product Code = JDI
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