Class 2 Device Recall Biomet Compehensive Reverse Shoulder

• Date Initiated by Firm: September 13, 2010
• Date Posted: December 16, 2010
• Recall Status: Terminated on July 27, 2011
• Recall Number: Z-0713-2011
• Recall Event ID: 57220
• 510(K)Number: K080642
• Product Classification: Shoulder Metal/Polymer Semi-Constrained Cemented Prosthesis - Product Code KWS
• 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.
• Code Information: Lot numbers: 068700, 246790, 314260, 437920, 557030, 608210, 746530, 787230, 810390 and 883100.
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582
• For Additional Information Contact: 574-267-6639 Ext. 1676
• Manufacturer Reason for Recall: The firm received complaints regarding fracturing of the device.
• FDA Determined Cause: Pending
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KWS