Recall Z-2292-2016 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
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 degenerative, post-traumatic or rheumatic diseases. " Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR). " Acute tra
| Date | Jul 26, 2016 (initiated Jun 30, 2016) |
| Status | Terminated |
| Reason | Product mix-up. The Avenir Mller Stem 6 lateral uncemented might be placed in the packaging of the Avenir Mller Stem 4 standard uncemented and vice versa. Potential for delay in surgery, and/or potential for use of incorrect implant which may in turn lead dismetry in patient and possibly the need for revision. |
| Root cause | Labeling mix-ups |
| Action | Zimmer Biomet sent an Urgent Medical Device Recall letter dated June 30, 2016 to all affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were instructed to review the notification immediately and ensure affected personnel are aware of the contents and assist Zimmer Biomet sales representative with the quarantine of any affected device. Your Zimmer Biomet sales representative will remove any affected device. Custome |
| Quantity | 2 |
| Distribution | Nationwide Distribution to OH and NM |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123392 | AVENIR MULLER STEM Zimmer GmbH, Mar 4, 2013 |