Recall Z-0712-2011 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Biomet, Inc.
Comprehensive Reverse Shoulder Humeral Tray with Locking Ring, 49 mm standard, sterile, REF 115350, Biomet Orthopedics, Warsaw, IN Intended for total shoulder replacement in a reverse configuration.
| Date | Dec 16, 2010 (initiated Sep 13, 2010) |
| Status | Terminated |
| Reason | The firm received complaints regarding fracturing of the device. |
| Root cause | Pending |
| Action | The firm sent "URGENT MEDICAL DEVICE RECALL NOTICE" dated 9/13/2010 to their distributors and customers. The letters stated the reason for the recall and what may happen as a result of the fracture of the device. The notices stated that the recalled devices should be immediately located, discontinued from use, and shipped back to Biomet. Customers should follow the instructions on the "FAX Back Response Form." If the affected product was further distributed, hospital personnel must be notified of the recall via the enclosed "Dear Biomet Customer" notice. The firm sent "URGENT MEDICAL |
| Quantity | 45 both products |
| Distribution | Nationwide Distribution -- NY, VA, MD, AL, CO, SD, TX, and OK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080642 | COMPREHENSIVE REVERSE SHOULDER Biomet, Inc., Jul 9, 2008 |