510(k) K010757 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
LFIT V40 FEMORAL HEAD COMPONENTS
| Applicant | Howmedica Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Apr 11, 2001 |
| Received | Mar 13, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010757
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 3, 2015 | Stryker Howmedica Osteonics Corp. LFT v40 Femoral Head; Catalog Number 6260-9-032;
V40 CoCr LFit Head 32mm/-4.
Designed to be assembled onto a femoral hip stem trunnion during surgery for a total hip arthroplasty. Terminated |
JDI | None listed |
| Nov 23, 2009 | Stryker Howmedica Osteonics Corp. Stryker Howmedica Osteonics, Skirted 5 40' Taper V40 Femoral Head (26 mm +8mm offset), hip prosthesis component. Terminated |
JDG | None listed |
| Nov 23, 2009 | Stryker Howmedica Osteonics Corp. Stryker Howmedica Osteonics, Skirtless 5 40' LFIT V40 Femoral Head (32 mm +0 mm offset); hip prosthesis component. Terminated |
JDG | None listed |
| Feb 7, 2008 | Stryker Howmedica Osteonics Corp. Stryker COCR V40 Femoral Head; xx-Long (+16mm) Neck Length, 26mm Diameter ; Sterile, Forged Vitallium Alloy, Product Number: 6260-5-526; Howmedica Osteonics Corp. Styrker Ireland; Carrigtwohill county Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.