Class 2 Device Recall

• Date Initiated by Firm: October 04, 2005
• Date Posted: November 18, 2005
• Recall Status: Terminated on May 04, 2006
• Recall Number: Z-0168-06
• Recall Event ID: 33895
• 510(K)Number: K022461
• Product Classification: Screw, Fixation, Bone - Product Code HWC
• Product: S2 System, Condyle Screw
• Code Information: Catalog No. 1795-5090S to 1795-5120S
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430-2002
• For Additional Information Contact: Dominick Cristofolo; 201-831 Ext. 5247
• Manufacturer Reason for Recall: Stryker Orthopaedics was informed by the manufacturer, that in some instances, the sterile blister package of the referenced G/K, T2 condyle and some S2 screw products may become damaged during shipping and handling which may result in a potential breach of the sterile barrier.
• FDA Determined Cause: Other
• Action: The product recall will extend to all branches.agencies and hospitals that have received the product.
• Quantity in Commerce: 532 units
• Distribution: nationwide
• 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 = HWC