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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker T2

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  Class 2 Device Recall Stryker T2 see related information
Date Initiated by Firm September 27, 2007
Date Posted November 16, 2007
Recall Status1 Terminated 3 on May 08, 2008
Recall Number Z-0214-2008
Recall Event ID 45106
510(K)Number K003018  
Product Stryker T2 Locking Screw, Fully threaded; 05 x 70mm, Catalog Number: 1896-5070S, Sterile, Qty: 1,Stryker Trauma GMbH, 24232 Schonkirchen, Germany
Distributed in the United States by Howmedica Osteonics Corp.; 325 Corporate Drive, Mahwah, NJ 07430
Code Information Catalog number: 189605970S: Lot Code K871252
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact
201-831-5000
Manufacturer Reason
for Recall		 Mislabeled: One lot of screws (05x70mm) is labeled as containing 70mm, but may actually contain 75mm length screws.
FDA Determined
Cause 2		 Packaging process control
Action Urgent Product Recall letters were sent on September 27, 2007, to all Stryker Branches/Agencies and hospitals who received the product requesting them to remove and quarantine the product for Stryker pick-up.
Quantity in Commerce 50
Distribution Nationwide
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 = and Original Applicant = HOWMEDICA OSTEONICS CORP.
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