Class 2 Device Recall Stryker T2

• Date Initiated by Firm: September 27, 2007
• Date Posted: November 16, 2007
• Recall Status: Terminated 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: 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 =