—#95618

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.

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: 216080, 216090, 216100, 551630, 877130, 8877160, 877180 and 877200.

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 #95618. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.