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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Compehensive Reverse Shoulder

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  Class 2 Device Recall Biomet Compehensive Reverse Shoulder see related information
Date Initiated by Firm September 13, 2010
Date Posted December 16, 2010
Recall Status1 Terminated 3 on July 27, 2011
Recall Number Z-0712-2011
Recall Event ID 57220
510(K)Number K080642  
Product Classification Shoulder Metal/Polymer Semi-Constrained Cemented Prosthesis - Product Code KWS
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.
Code Information Lot numbers: 216080, 216090, 216100, 551630, 877130, 8877160, 877180 and 877200.
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 2		 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 and Original Applicant = BIOMET, INC.
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