| Date Posted |
December 16, 2010 |
| Recall Number |
Z-0712-2011 |
| Product |
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. |
| Code Information |
Lot numbers: 216080, 216090, 216100, 551630, 877130, 8877160, 877180 and 877200. |
Recalling Firm/
Manufacturer |
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582 |
| Consumer Instructions |
No consumer action necessary |
Reason for
Recall |
The firm received complaints regarding fracturing of the device. |
| 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 DEVICE RECALL NOTICES’ to implanting surgeons. These letters informed the surgeons of the recall and instructed them to continue to monitor the patient for fracture of the device. Customers are to confirm receipt of the notice by calling 800-348-9500 ext 3755 or 3983. Questions should be directed to 574-371-3755 or 574-372-3983. |
| Quantity in Commerce |
45 both products |
| Distribution |
Nationwide Distribution — NY, VA, MD, AL, CO, SD, TX, and OK. |
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