Class 2 Device Recall

• Date Initiated by Firm: April 04, 2005
• Date Posted: October 07, 2005
• Recall Status: Terminated on August 15, 2007
• Recall Number: Z-0011-06
• Recall Event ID: 31984
• Product Classification: Orthopedic Manual Surgical Instrument - Product Code LXH
• Product: Allocraft TLIF Bone Inserter.
• Code Information: Catalog No. 483600100; Lot Code: 04C570
• FEI Number: 3003070421
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430-2002
• For Additional Information Contact: Dominick Cristofolo; 201-831-5247
• Manufacturer Reason for Recall: Stryker was made aware that the short arm of the bone inserter may fracture during use and potentially result in an adverse health consequence.
• FDA Determined Cause: Other
• Action: The firm sent notification letters to their branches/agencies on 4/4/2005. 100% effectiveness to be achieved by completing Product Accountability forms, follow up telephone calls, and follow-up letters as required.
• Quantity in Commerce: 9
• Distribution: The product was distributed to the firm''s branches/Agencies that distribute the product to hospitals, etc. There are 8 locations.
• 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.