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U.S. Department of Health and Human Services

Class 3 Device Recall Stryker Howmedica Osteonics

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  Class 3 Device Recall Stryker Howmedica Osteonics see related information
Date Initiated by Firm December 02, 2002
Date Posted January 28, 2003
Recall Status1 Terminated 3 on August 01, 2003
Recall Number Z-0467-03
Recall Event ID 25321
510(K)Number K944836  
Product Classification Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate - Product Code MEH
Product Restoration #8 HA Hip Stem, Catalog No. 6013-1216 and Restoration #8 HA Hip Stem, Catalog No. 6013-1218.
Code Information Catalog No. 6013-1216 -- Lot Code: 37778302; Catalog No. 6013-1218 -- Lot Code: 37778401.
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics
300 Commerce Court
Mahwah NJ 07430
For Additional Information Contact Tom Grzeskowiak
201-831-5495
Manufacturer Reason
for Recall
Product mix-up. 16mm stem in a 18mm package.
FDA Determined
Cause 2
Other
Action Branches and agents were notified via letter on 12/2/2002. Hospitals were notified on 12/2/2002 via FedEx to OR Supervisors.
Quantity in Commerce 6
Distribution The product was shipped to 2 Howmedica branches, 1 hospital, one government hospital, and 2 international distributors. Government hospital is the VA Medical Center, Tampa, FL.. Two international customers are Stryker Howmedica affiliates in Chile and Spain.
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 = MEH and Original Applicant = OSTEONICS CORP.
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