REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found in REF 32-422763 Oxford Mlcroplasty Knee System T

FDA device recall Z-1124-2013 · posted 2013-04-15 · Terminated

Recall details

Recalling firm

Biomet U.K., Ltd.

Reason for recall

Investigation of complaints found excessive use of the instrument could result in cracking on the weld between the head and the handle, which could lead to part of the head becoming detached from the handle.

Action taken

BIOMET sent an Urgent Medical Device Recall Notice on March 20, 2013, to all affected customers with directions to forward the notice if product was further distributed to Hospital Operating Room managers. The notice identified the recalled device, reason for the recall, and possible adverse events directing consignees to locate and discontinue use of the device. A FAX back Response form was to be returned to 574-372-1683 within 3 days of receipt prior to return of the product to Biomet, USA. Questionsregarding this recall should be addressed to 574 372-1570 M-F, 8a.m. -5 p.m.

Root cause

Device Design

Status

Terminated

Product code

NRA

Quantity affected

430

Distribution

Worldwide Distribution - USA (nationwide), Europe, Japan, Australia, Canada, Singapore, South Africa, and Costa Rica.

Date initiated

2013-03-20

Date posted

2013-04-15

Date terminated

2015-05-04

Location

South Wales, Bridgend, United Kingdom