510(k) K190656 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Dec 6, 2019 |
| Received | Mar 14, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190656
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2025 | Zimmer, Inc. Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis Open, Classified |
LPH | None listed |
| Nov 3, 2025 | Zimmer, Inc. Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110031013; semi constrained hip prosthesis Open, Classified |
LPH | None listed |
| Aug 14, 2020 | Zimmer Biomet, Inc. Dual Mobility Vivacit-E Bearing, Model Number 110031009 Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.