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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Orthopaedics

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  Class 2 Device Recall Stryker Orthopaedics see related information
Date Initiated by Firm February 10, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on June 09, 2004
Recall Number Z-0719-04
Recall Event ID 28405
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Restoration Hip system Cylindrical Distal Extension. Catalog Numbers 1212-3105, 1212-3115, 1212-3125, and 1212-3195. Sizes 12.5mm, 11.5mm, 19.5mm, and 10.5mm extensions.
Code Information Lots: 96910501; 96949401; 96940901;  96950901.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics
325 Corporate Drive
Mahwah NJ 07430
For Additional Information Contact Dominick Cristofolo
201-831-5247
Manufacturer Reason
for Recall		 The Cylindrical Distal Extensions were incorrectly coded and packaged.
FDA Determined
Cause 2		 Other
Action Stryker Orthopaedics sent product recall letters to the Branch/Agency involved on 2/10/2004 via FedEx. International distributor was sent notification on 2/10/2004.
Quantity in Commerce 20
Distribution The 9 units were sent out to 2 US branch/agents and one international distributor.
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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