Recall Z-1284-2023 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Biomet, Inc.
G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462
| Date | Mar 23, 2023 (initiated Feb 6, 2023) |
| Status | Open, Classified |
| Reason | The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner. |
| Root cause | Under Investigation by firm |
| Action | An "URGENT MEDICAL DEVICE RECALL" notification letter dated 2/6/23 was sent to customers. The customers were instructed to do the following: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Inventory Return Certification Form for each return and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have |
| Quantity | 12 units |
| Distribution | US Distribution to states of: AZ, FL, GA, MI, NE, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150522 | G7 Dual Mobility System Biomet, Inc., May 1, 2015 |