Class 2 Device Recall Stryker

• Date Initiated by Firm: December 27, 2004
• Date Posted: January 15, 2005
• Recall Status: Terminated on March 18, 2005
• Recall Number: Z-0401-05
• Recall Event ID: 30759
• 510(K)Number: K993166
• Product Classification: Screw, Fixation, Bone - Product Code HWC
• Product: Stryker brand Bioabsorbable ACL Interference Screw, 10mm X 35mm; 12mm X 35mm Part Numbers: 234-010-078; 234-010-080
• Code Information: Part Number: 234-010-078, Lot # 32101; Part Number: 234-010-080, Lot # 32103
• Recalling Firm/ Manufacturer: Stryker Endoscopy; 5900 Optical Ct; San Jose CA 95138-1400
• For Additional Information Contact: Customer Service; 800-624-4422
• Manufacturer Reason for Recall: The label on the outside of the shipping box has an incorrect description of the screw diameter.
• FDA Determined Cause: Other
• Action: Consignees have been alerted by phone calls on 12/16/2004. Formal advisory notice was sent out on 12/27/2004. All international consignees have also been alerted.
• Quantity in Commerce: 16 units of 078, 284 units of 080
• Distribution: 6 consignees (locations to be determined) received 15 units. the remaining 147 units were distributed to international divisions.
• 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