Class 2 Device Recall Restoration

• Date Initiated by Firm: December 30, 2003
• Date Posted: July 20, 2004
• Recall Status: Terminated on February 07, 2006
• Recall Number: Z-0571-04
• Recall Event ID: 28052
• 510(K)Number: K013106 K983404
• Product Classification: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented - Product Code LZO
• Product: Restoration T3 Revision Hip System, Femoral Hip Prosthesis. Various lengths and Model numbers. 6260-3-014 T3 MOD REV DIST STM 14MMX225MM; 6260-3-015 T3 MOD REV DIST STM 15MMX225MM; 6260-3-016 T3 MOD REV DIST STM 16MMX225MM; 6260-3-017 T3 MOD REV DIST STM 17MMX225MM; 6260-3-018 T3 MOD REV DIST STM 18MMX225MM; 6260-3-019 T3 MOD REV DIST STM 19MMX225MM; 6260-3-020 T3 MOD REV DIST STM 20MMX225MM; 6260-3-022 T3 MOD REV DIST STM 22MMX225MM; 6230-3-024 T3 MOD REV DIST STM 24MMX225MM; 6260-3-114 T3 MOD REV DIST STM 14MMX265MM; 6260-3-115 T3 MOD REV DIST STM 15MMX265MM; 6260-3-116 T3 MOD REV DIST STM 16MMX265MM; 6260-3-117 T3 MOD REV DIST STM 17MMX265MM; 6260-3-118 T3 MOD REV DIST STM 18MMX265MM; 6260-3-119 T3 MOD REV DIST STM 19MMX265MM; 6260-3-120 T3 MOD REV DIST STM 20MMX265MM; 6260-3-122 T3 MOD REV DIST STM 22MMX265MM; 6260-3-124 T3 MOD REV DIST STM 24MMX265MM; 6260-3-214 KINKED T3 DIST STM 14MMX265MM; 6260-3-215 KINKED T3 DIST STM 15MMX265MM; 6260-3-216 KINKED T3 DIST STM 16MMX265MM; 6260-3-217 KINKED T3 DIST STM 17MMX265MM; 6260-3-218 KINKED T3 DIST STM 18MMX265MM; 6260-3-219 KINKED T3 DIST STM 19MMX265MM; 6260-3-220 KINKED T3 DIST STM 20MMX265MM; 6260-3-222 KINKED T3 DIST STM 22MMX265MM; 6260-3-224 KINKED T3 DIST STM 24MMX265MM; 6260-3-314 KINKED T3 DIST STM 14MMX305MM; 6260-3-315 KINKED T3 DIST STM 15MMX305MM; 6260-3-316 KINKED T3 DIST STM 16MMX305MM; 6260-3-317 KINKED T3 DIST STM 17MMX305MM; 6260-3-318 KINKED T3 DIST STM 18MMX305MM; 6260-3-319 KINKED T3 DIST STM 19MMX305MM; 6260-3-320 KINKED T3 DIST STM 20MMX305MM; 6260-3-322 KINKED T3 DIST STM 22MMX305MM; 6260-3-324 KINKED T3 DIST STM 24MMX305MM; LR3ST RESTORATION REV HIP SYS SURGICAL TECHNIQUE; 6262-7-000-0 RESTORATION REV HIP SYS TEMPLATE SET FOR STRAIGHT STEMS ONLY; LTEM71 1-9 RESTORATION REV HIP SYS 265MM BOWED STEM TEMPLATES; LTEM72 1-9 RESTORATION REV HIP SYS 305MM BOWED STEM TEMPLATES.
• Code Information: All Lots
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics; 300 Commerce Ct; Mahwah NJ 07430-2104
• For Additional Information Contact: Dominick Cristofolo; 201-831-5247
• Manufacturer Reason for Recall: Restoration T3 Revision Hip System distal stem has demonstrated fractures.
• FDA Determined Cause: Other
• Action: Product recall letters and accountability forms were sent via FedEx on 12/30/2003 with return receipt.
• Quantity in Commerce: 8986
• Distribution: The following direct accounts received the device: Branches/Agencies: 46; Hospitals: 526; Government Hospitals: 23; International Distributors: 10; Latin America: 3; Canada: 1; and Asia Pacific: 3.
• 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 = LZO; 510(K)s with Product Code = LZO