Custom Comprehensive Shoulder Bio-Modular Base, 44 mm Humeral Tray standard, sterile, REF CP561510, Biomet Orthopedics,
FDA device recall Z-0713-2011 · posted 2010-12-16 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The firm received complaints regarding fracturing of the device.
- 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.
- Root cause
- Pending
- Status
- Terminated
- Product code
- KWS
- Quantity affected
- 45 both products
- Distribution
- Nationwide Distribution -- NY, VA, MD, AL, CO, SD, TX, and OK.
- Date initiated
- 2010-09-13
- Date posted
- 2010-12-16
- Date terminated
- 2011-07-27
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COMPREHENSIVE REVERSE SHOULDER (K080642) | Biomet, Inc. | 2008-07-09 |