510(k) K123392 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
AVENIR MULLER STEM
| Applicant | Zimmer GmbH, Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 4, 2013 |
| Received | Nov 2, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123392
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 31, 2018 | Zimmer GmbH Avenir Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 - Product Usage: Avenir@ Muller Stems are intended to reduce pain and increase hip mobility through long term cemen Terminated |
LZO | None listed |
| Feb 28, 2018 | Zimmer GmbH Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368 Terminated |
LZO | None listed |
| Feb 28, 2018 | Zimmer GmbH Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)00889024479500 (17)220430 (10)2905496 Terminated |
LZO | None listed |
| Jul 26, 2016 | Zimmer Gmbh Avenir Mller Stem 4 Standard
Avenir Mller Stem 6 Lateral
Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis
Intended Use: " Advanced wear of the joint due to Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.