Recalls / —
—#95619
Product
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.
- FDA product code
- KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K080642
- Affected lot / code info
- Lot numbers: 068700, 246790, 314260, 437920, 557030, 608210, 746530, 787230, 810390 and 883100.
Why it was recalled
The firm received complaints regarding fracturing of the device.
Root cause (FDA determination)
Pending
Action the firm took
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.
Recalling firm
- Firm
- Biomet, Inc.
- Address
- 56 E Bell Dr, Warsaw, Indiana 46582
Distribution
- Distribution pattern
- Nationwide Distribution -- NY, VA, MD, AL, CO, SD, TX, and OK.
Timeline
- Recall initiated
- 2010-09-13
- Posted by FDA
- 2010-12-16
- Terminated
- 2011-07-27
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #95619. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.