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U.S. Department of Health and Human Services

Class 2 Device Recall Restoration

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  Class 2 Device Recall Restoration see related information
Date Initiated by Firm December 30, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on February 07, 2006
Recall Number Z-0571-04
Recall Event ID 28052
510(K)Number K983404  K013106  
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 2
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 and Original Applicant = HOWMEDICA CORP.
510(K)s with Product Code = LZO and Original Applicant = HOWMEDICA OSTEONICS CORP.
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