510(k) K181171 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Zimmer Biomet Ceramic Heads
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Apr 2, 2019 |
| Received | May 2, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181171
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 21, 2025 | Zimmer, Inc. Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-
Porous, Uncemented Open, Classified |
LZO | None listed |
| Apr 21, 2025 | Zimmer, Inc. Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-
Porous, Uncemented Open, Classified |
LZO | None listed |
| Apr 21, 2025 | Zimmer, Inc. Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 802802201; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-
Porous, Uncemented Open, Classified |
LZO | None listed |
| Apr 21, 2025 | Zimmer, Inc. Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-
Porous, Uncemented Open, Classified |
LZO | None listed |
| Apr 21, 2025 | Zimmer, Inc. Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-
Porous, Uncemented Open, Classified |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.