Z-0571-04

Restoration T3 Revision Hip System, Femoral Hip Prosthesis. Various lengths and Model numbers. 6260-3-014 T3...

Name: Z-0571-04 Restoration T3 Revision Hip System, Femoral Hip Prosthesis. Various lengths and Model numbers. 6260-3-014 T3...
Creator: Stryker Howmedica Osteonics
Published: 2003-12-30
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2003-12-30 / Terminated

FDA source

Stryker Howmedica Osteonics began a recall of 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... on 2003-12-30. The reason FDA records is "Restoration T3 Revision Hip System distal stem has demonstrated fractures". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0571-04
Status: Terminated
Initiated: 2003-12-30
Posted: 2004-07-20
Terminated: 2006-02-07
Recalling firm: Howmedica Osteonics Corp
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.
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: Restoration T3 Revision Hip System distal stem has demonstrated fractures.
FDA root 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.
Product codes and lots: All Lots

Product code LZO

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)