Custom Comprehensive Shoulder Bio-Modular Base, 44 mm Humeral Tray standard, sterile, REF CP561510, Biomet Orthopedics, Warsaw, IN Intended for total shoulder replacement in a reverse configuration.
This recall has been terminated (originally issued December 16, 2010).
- Company
- Biomet, Inc.
- Recall Initiated
- September 13, 2010
- Posted
- December 16, 2010
- Terminated
- July 27, 2011
- Recall Number
- Z-0713-2011
- Quantity
- 45 both products
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The firm received complaints regarding fracturing of the device.
Distribution
Nationwide Distribution -- NY, VA, MD, AL, CO, SD, TX, and OK.
Lot / Code Info
Lot numbers: 068700, 246790, 314260, 437920, 557030, 608210, 746530, 787230, 810390 and 883100.
Root Cause
Pending
Action Taken
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.