Recall Z-0972-2019 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Zimmer Biomet, Inc.
Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.
| Date | Dec 21, 2018 |
| Status | Terminated |
| Reason | The product was potentially being packaged without a taper adapter. |
| Root cause | Packaging process control |
| Action | The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL" letters dated 12/21/18 to customers. The letters described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have unconsumed 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 Acknowledg |
| Quantity | 52 |
| Distribution | US Distribution to states of:: AR, KY, and WA.; Internationally to: Australia and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120121 | COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE Biomet, Inc., Feb 16, 2012 |