Recall Z-0644-2019 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
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 cementless fixation of total or hemi hip arthroplasty in the femur of patients with an adequate bone stock to support the component. A system consisting of a stem, a ball head and a cup is used for the tre
| Date | Oct 31, 2018 |
| Status | Terminated |
| Reason | Mislabeled Labeled Avenir Mller Stem size 1, the stem inside the packaging is an Avenir Mller Stem size 2 . |
| Root cause | Process control |
| Action | Zimmer Biomet issued Notices to the OUS consignees on October 31, 2018. Letter identifies action to be taken: Review this notice and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement |
| Quantity | 13 units |
| Distribution | International distribution in the countries of Germany and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123392 | AVENIR MULLER STEM Zimmer GmbH, Mar 4, 2013 |