510(k) K972435 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM
| Applicant | Johnson & Johnson Professionals, Inc., Raynham MA, US |
| Decision | Substantially Equivalent, Sep 11, 1997 |
| Received | Jun 30, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972435
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2012 | DePuy Orthopaedics, Inc. ULTIMA*LX STM,POL 10/12TAP/SZ1
Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to Terminated |
JDI | None listed |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. ULTIMA*LX STM,POL 10/12TAP/SZ2
Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to Terminated |
JDI | None listed |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. ULTIMA*LX STM,POL 10/12TAP/SZ3
Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to Terminated |
JDI | None listed |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. ULTIMA*LX STM,POL 10/12TAP/SZ4
Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to Terminated |
JDI | None listed |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. ULTIMA*LX STM,POL 10/12TAP/SZ5
Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to Terminated |
JDI | None listed |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. ULTIMA*LX STM,POL 10/12TAP/1M
Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to Terminated |
JDI | None listed |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. ULTIMA*LX STM,POL 10/12TAP/2M
Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to Terminated |
JDI | None listed |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. ULTIMA*LX STM,POL 10/12TAP/3M
Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to Terminated |
JDI | None listed |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. ULTIMA*LX STM,POL 10/12TAP/4M
Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.