Recall Z-1208-2015 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Biomet, Inc.
Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400
| Date | Feb 24, 2015 (initiated Jan 7, 2015) |
| Status | Terminated |
| Reason | The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes. |
| Root cause | Process control |
| Action | Biomet issued written notices on 1/7/2015, Requested completion and submission of response/effectiveness forms for Product Part Number: 01 0000589 Product Description: Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adapter, Expiration October 2024. Questions related to this notice should be directed to Audrey Daenzer, Field Action Specialist (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m. |
| Quantity | 11- 6 consumed, 5 with distributors |
| Distribution | Domestic: AL, FL, NY, TX Foreign: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120121 | COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE Biomet, Inc., Feb 16, 2012 |