Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee joint replacement prostheses int

FDA device recall Z-0533-2013 · posted 2012-12-17 · Terminated

Recall details

Recalling firm

Biomet, Inc.

Reason for recall

Biomet investigation identified that the square end of the offset tibial tray adaptor locking insert is oversized and may not engage insert tool screwdriver. This could cause a possible delay in surgery greater than 30 minutes, potentially exposing the patient to the increased risks from being under anesthesia for a longer duration.

Action taken

Biomet Recall sent an Urgent Medical Device Recall Notices letter dated November 15, 2012 to distributors, hospital operating room(OR)managers and Surgeons receiving the affected product. The letter identified the affected product, the reason for the recall and actions to be take, including directions to immediately locate and discontinue use of the affected product. Customers were asked to confirm receipt of the notice by calling 1-888-348-9500 extension 1570. Customers with affected product to be returned are asked to obtain RGA # by calling 574-372-6677 or email: rgarequest@biomet.com. A FAX Back Response Form is to be filled out and sent within 3 days of receipt to 574-372-1683. Return product to the Attention of Audrey Daenzer, Field Action Coordinator, Biomet, Attention Return Goods, Building B Recalls, 56 East Bell Drive, Warsaw, IN 46580. Questions related to the notice should be directed to 474-372-3983 or 574-371-3009, Monday- Friday 8 a.m. to 5 p.m.

Root cause

Employee error

Status

Terminated

Product code

MBV

Quantity affected

200

Distribution

Worldwide distribution - USA (nationwide) and the countries of Australia, Canada, Chile, Europe, Japan, Korea, Panama, Puerto Rico and Thailand.

Date initiated

2012-11-15

Date posted

2012-12-17

Date terminated

2013-11-08

Location

Warsaw, IN

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