Recall Z-1103-2017 ยท PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
Zimmer Biomet, Inc.
Comprehensive Reverse Shoulder System Humeral Tray Model 115340
| Date | Feb 11, 2017 (initiated Dec 20, 2016) |
| Status | Terminated |
| Reason | Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing. |
| Root cause | Device Design |
| Action | On 12/20/2016, URGENT MEDICAL DEVICE RECALL-LOT SPECIFIC notifications were sent to the affected Risk Managers and Distributors via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. On 2/1/2017, URGENT MEDICAL DEVICE RECALL-LOT SPECIFIC notifications were sent to the affected Surgeons, Risk Managers, and Distributors via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibil |
| Quantity | 4388 |
| Distribution | Nationwide. CANADA AUSTRALIA CHILE COLOMBIA KOREA Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080642 | COMPREHENSIVE REVERSE SHOULDER Biomet, Inc., Jul 9, 2008 |