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Oct 05

POTENTIALLY DEFECTIVE BIOMET REVERSE SHOULDER IMPLANT

Biomet may have produced and sold defective reverse shoulder implants.  In 2010 Biomet, Inc. issued a recall notice for is reverse shoulder implant that has repeatedly failed.  The FDA has determined that this is a Class 2 Recall.  On 9/13/2010 Biomet sent all its customers an “URGENT MEDICAL DEVICE RECALL NOTICE.”

The recall might have been necessitated by a design or manufacturing defect in the shoulder implant.  If your Bimomet reverse shoulder implant has failed you should consider consulting with a products liability or medical malpractice attorney about remedies to which you may be entitled.  For a free consultation contact:

Gregory A. Hall
Law Office of Gregory A. Hall
3570 E. 12 Avenue, Suite 200
Denver, CO 80206
Ph. 303-320-0584
Email: gregory@federallaw.com
Web: http://www.adenverlawyer.com

 

Class 2 Recall
Biomet Compehensive Reverse Shoulder
see related information
Date Posted December 16, 2010
Recall Number Z-0712-2011
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, Indiana 46582
Consumer Instructions No consumer action necessary
Reason for
Recall
The firm received complaints regarding fracturing of the device.
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.

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