Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill guide. The Oxford Fixed Bearing Knee is a Partial kne

FDA device recall Z-2065-2015 · posted 2015-07-14 · Terminated

Recall details

Recalling firm

Biomet, Inc.

Reason for recall

Oxford Femoral Drill Guide Lateral IM Adapter may have an undersized diameter that can cause an interference with PN: 32-422822, Oxford Microplasty IM Link.

Action taken

On 6/3/2015 an "URGENT MEDICAL DEVICE RECALL NOTICE" letter was sent to the affected distributors with instructions for locating and returning the affected product. The recall letter included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Root cause

Component design/selection

Status

Terminated

Product code

HWT

Quantity affected

18

Distribution

Worldwide Distribution - US Nationwide in the states of NC, IN, PA, OH and the country of the Netherlands.

Date initiated

2015-06-03

Date posted

2015-07-14

Date terminated

2016-03-15

Location

Warsaw, IN