Recall Z-0007-2023 ยท OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
Zimmer, Inc.
G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
| Date | Oct 5, 2022 (initiated Aug 25, 2022) |
| Status | Open, Classified |
| Reason | The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of surgery, or infection leading to surgical intervention. |
| Root cause | Under Investigation by firm |
| Action | On August 25, 2022, the firm notified affected customers via Urgent Medical Device Recall letters. Customers were instructed to quarantine all affected product. Zimmer Biomet sales representatives will remove the affected product from customer facilities. Customers should ensure that affected personnel are aware of the recall, and also notify any recipients if the product has been further distributed. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outsid |
| Quantity | 56 US |
| Distribution | Domestic distribution US nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121874 | G7 ACETABULAR SYSTEM Biomet Manufacturing Corp, Nov 23, 2012 |