Class 3 Device Recall Howmedica

• Date Initiated by Firm: August 04, 2003
• Date Posted: October 15, 2003
• Recall Status: Terminated on September 30, 2003
• Recall Number: Z-1295-03
• Recall Event ID: 26996
• 510(K)Number: K003018
• Product Classification: Rod, Fixation, Intramedullary And Accessories - Product Code HSB
• Product: T2 Tibia Nail, Standard 9 x 300 mm, T2 Tibia System, Catalog No. 1822-0930S.
• Code Information: Lot K884459
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics; 300 Commerce Court; Mahwah NJ 07430
• For Additional Information Contact: Dominick Cristofolo; 201-837-5247
• Manufacturer Reason for Recall: The device does not have an oblong hole for dynamic locking as required.
• FDA Determined Cause: Other
• Action: Product recall letters and Product accountability forms were sent via FedEx on 8/4/2003 with return receipt.
• Quantity in Commerce: 6
• Distribution: The 6 units were distributed to Howmedica Branch and sales agents located in PA, VA, GA, KS, and CA.
• 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 = HSB