Recall Z-1173-2018 ยท KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Biomet, Inc.
Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction
| Date | Mar 23, 2018 (initiated Feb 28, 2018) |
| Status | Terminated |
| Reason | During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch between the screw holes in the Humeral Body & Elbow Condyle affects assembly during surgery. If the product has already been implanted, no action is required. The mismatch is estimated to prevent screw engagement in less than 1% of cases. |
| Root cause | Under Investigation by firm |
| Action | An URGENT MEDICAL DEVICE RECALL letter will be issued to customers titled "Affected Product: Comprehensive Segmental Revision System (SRS)" instructing customers to do the following: Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have 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 the attached Certificate of Acknowledgement and send to |
| Quantity | 634 |
| Distribution | Distribution US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111746 | COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS) Biomet, Inc., Dec 15, 2011 |