510(k) K840643 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
HARRIS-GALANTE POROUS TOTAL HIP SYS
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Apr 17, 1984 |
| Received | Feb 15, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K840643
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2016 | Zimmer Manufacturing B.V. Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515
Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520
Hgp ii acetabular cup bone screw selftap 6.5x25mm 00662406525
Hgp ii acetabu Terminated |
JDI | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 12 consists of all product under product code JDI
, and same usage:
Item no:
902602935 6 DEGREE COCR FEM HEAD 28
902602835 6 DEGREE COCR FEM HEAD 28
902603235 6 DEGREE COCR FEM HEAD 32
902603 Terminated |
JDI | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 28 consists of all product under product code: JDI and same usage:
Item no:
32902605000 FEMORAL HD 28MM MEDIUM
32902604000 FEMORAL HD 28MM SHORT
32902604035 FEMORAL HD 28MM SHT+ 3.5M
For use Terminated |
JDI | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 33 consists of all product under product code: JDI and same usage:
Item no:
662406515 HGP II ACETABULAR CUP BON
662406520 HGP II ACETABULAR CUP BON
662406525 HGP II ACETABULAR CUP BON
662406 Terminated |
JDI | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 39 consists of all product under product code: JDI
and same usage:
Item no:
32902605800 ION IMPLANTED FEM 22MM LO
32902604900 ION IMPLANTED FEM 26MM ME
32902603900 ION IMPLANTED FEM 26MM SH
Terminated |
JDI | None listed |
| Feb 20, 2014 | Zimmer, Inc. HGP II ACETABULAR CUP BON Terminated |
JDI | None listed |
| Feb 20, 2014 | Zimmer, Inc. 6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE Terminated |
JDI | None listed |
| Feb 20, 2014 | Zimmer, Inc. CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes) Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.