Recall Z-0057-2021 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Zimmer Biomet, Inc.
Dual Mobility Vivacit-E Bearing, Model Number 110031009
| Date | Aug 14, 2020 |
| Status | Terminated |
| Reason | The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Recall notification letters dated 8/14/20 were sent to customers. Risk Manager Responsibilities: 1. Review this notification 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 and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form will be returned even if you do not ha |
| Quantity | 31 |
| Distribution | Products were distributed to the following US states: FL, ID, IL, IN, KY, MA, MD, MI, MN, NC, NJ, OH, OR, PA, SC, TX, UT, VA, WI, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190656 | Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings Zimmer, Inc., Dec 6, 2019 |