510(k) K911684 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
BIOMET COBALT-CHROME FEMORAL COMPONENTS
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent for Some Indications, Jun 27, 1991 |
| Received | Apr 16, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911684
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2018 | Zimmer Biomet, Inc. Modular Head Component, Biomet Hip System; Item No. 163669, Hip Joint, metal/polymer semi-constrained cemented prosthesis
The device is used in treatment of patients who need total hip arthroplasty, Terminated |
JDI | None listed |
| Jun 11, 2015 | Biomet, Inc. Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM MOD HEAD COCR -3 MM NECK; 32MM MOD HEAD COCR STD NECK ; 32MM MOD HEAD COCR +3MM NECK; 32MM COCR MOD HD +6MM NO SKIRT
Hip j Terminated |
JDI | None listed |
| Sep 24, 2003 | Biomet, Inc. Stanmore modular hip system; Stanmore CoCr femoral size 1 std. stem; part 164241 Terminated |
JDI | None listed |
| Sep 24, 2003 | Biomet, Inc. Stanmore modular hip system; Stanmore CoCr femoral size 2 std. stem; part 164242 Terminated |
JDI | None listed |
| Sep 24, 2003 | Biomet, Inc. Stanmore modular hip system; Stanmore CoCr femoral size 3 std. stem; part 164243 Terminated |
JDI | None listed |
| Sep 24, 2003 | Biomet, Inc. Stanmore modular hip system; Stanmore CoCr femoral size 4 std. stem; part 164244 Terminated |
JDI | None listed |
| Sep 24, 2003 | Biomet, Inc. Stanmore modular hip system; Stanmore CoCr femoral size 5 std. stem; part 164245 Terminated |
JDI | None listed |
| Sep 24, 2003 | Biomet, Inc. Stanmore modular hip system; Stanmore CoCr femoral size 1 straight stem; part 164251 Terminated |
JDI | None listed |
| Sep 24, 2003 | Biomet, Inc. Stanmore modular hip system; Stanmore CoCr femoral size 2 straight stem; part 164252 Terminated |
JDI | None listed |
| Sep 24, 2003 | Biomet, Inc. Stanmore modular hip system; Stanmore CoCr femoral size 3 straight stem; part 164253 Terminated |
JDI | None listed |
| Sep 24, 2003 | Biomet, Inc. Stanmore modular hip system; Stanmore CoCr femoral size 4 straight stem; part 164254 Terminated |
JDI | None listed |
| Sep 24, 2003 | Biomet, Inc. Stanmore modular hip system; Stanmore CoCr femoral size 5 straight stem; part 164255 Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.