FDA Device

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

Hazard

Restoration T3 Revision Hip System distal stem has demonstrated fractures.

What You Should Do

Remedy

Product recall letters and accountability forms were sent via FedEx on 12/30/2003 with return receipt.

Products

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
Brand
Stryker Howmedica Osteonics
UPC
All Lots

Units Affected

8986