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 Recall Z-0712-2011 · Posted 2010-12-16
Advertisement
Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeKWS
Date Initiated2010-09-13
Date Terminated2011-07-27
Product Quantity45 both products
Reason for Recall
The firm received complaints regarding fracturing of the device.
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.
Root Cause
Pending
Distribution Pattern
Nationwide Distribution -- NY, VA, MD, AL, CO, SD, TX, and OK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement