510(k) K091973 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
METASUL TAPER LINERS, METASUL FEMORAL HEADS
| Applicant | Zimmer GmbH, Warsaw IN, US |
| Decision | Substantially Equivalent, Nov 17, 2009 |
| Received | Jul 1, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091973
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2019 | Zimmer Biomet, Inc. Metasul Taper Liner, various sizes, Item Nos. 00877000528
00877000628
00877000732
00877000832
00877000936
00877001036
00877001140
00877001240
00877001340
00877001440
00877001540
00877001640
0087700174 Terminated |
KWA | None listed |
| Oct 10, 2019 | Zimmer Biomet, Inc. Metasul Femoral Heads, various sizes, Item Nos. 00877004001
00877004002
00877004003
00877004004
00877004005 Terminated |
KWA | None listed |
| Feb 22, 2016 | Zimmer Biomet, Inc. Metasul Head 40, 12/14, SZ M/0
total hip prosthesis - metal femoral heads
Noninflammatory degenerative joint disease (NIDJD) including avascular necrosis, osteoarthritis, post-traumatic arthritis and Terminated |
KWA | None listed |
| Oct 25, 2013 | Zimmer, Inc. Metasul Head.
Intended for use either with or without bone cement in total hip arthroplasty. Terminated |
KWA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.