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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker LFIT V40

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  Class 2 Device Recall Stryker LFIT V40 see related information
Date Initiated by Firm September 04, 2009
Date Posted November 23, 2009
Recall Status1 Terminated 3 on June 26, 2013
Recall Number Z-0391-2010
Recall Event ID 53434
510(K)Number K010757  K993601  K022077  K061434  
Product Classification hip prosthesis component. - Product Code JDG
Product Stryker Howmedica Osteonics, Skirtless 5 40' LFIT V40 Femoral Head (32 mm +0 mm offset); hip prosthesis component.
Code Information Catalog number 6260-9-132; Lot Code 28759003
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah NJ 07430
For Additional Information Contact RIchard Wolyn
201-831-5158
Manufacturer Reason
for Recall		 Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head.
FDA Determined
Cause 2		 Process control
Action Stryker sent Notification letters and Product Accountability Forms via FedEx on September 4, 2009 with return receipt. Corrected letters were sent on September 9, 2009.
Quantity in Commerce 10 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.
510(K) Database 510(K)s with Product Code = JDG and Original Applicant = HOWMEDICA OSTEONICS CORP
510(K)s with Product Code = JDG and Original Applicant = HOWMEDICA OSTEONICS CORP.
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