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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 Recall
Biomet Compehensive Reverse Shoulder
see related information
Date Posted December 16, 2010
Recall Status1 Terminated on July 27, 2011
Recall Number Z-0713-2011
Recall Event ID 57220
Premarket Notification
510(K) Number
K080642 
Product Classification Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented - 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, Indiana 46582
Consumer Instructions No consumer action necessary
Manufacturer Reason
for Recall
The firm received complaints regarding fracturing of the device.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KWS and Original Applicant = BIOMET, INC.
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