Recall Z-0590-2019 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Zimmer Biomet, Inc.
Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394
| Date | Oct 10, 2018 |
| Status | Terminated |
| Reason | Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as the Bowed IM Stem lot. The associated risk of this product issue is a potential extension of surgery <30 minutes if a replacement is readily available. |
| Root cause | Under Investigation by firm |
| Action | On October 10, 2018, the firm notified affected customers via Urgent Medical Device Recall letters. Customers were advised of the product issue. Distributors were asked to take the following actions: 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. If the affected product is located at a hospital, remove the product from the hospital and provide the Risk Manager Recall Notice to the hospital and request that they sign the Certificate of Acknowledgement. 4. Immediately retu |
| Quantity | 3 total |
| Distribution | Distributed to accounts in IN, MD, MO, MS, and NM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002757 | ONCOLOGY SALVAGE SYSTEM Biomet, Inc., Nov 24, 2000 |