Oxford Femoral Knee System REF 154600, LOT 2272736, WARNING DO NOT RESTERILIZE, STERILE UNLESS PACK DAMAGED, BIOMET UK Ltd, (510K# K011138) This device is used in partial knee replacement surgery as a result of patients who are experiencing degenerative arthritis.

This recall has been terminated (originally issued June 29, 2011).

Recall Initiated

April 22, 2011

Posted

June 29, 2011

Terminated

August 3, 2011

Recall Number

Z-2698-2011

Quantity

12 devices

Official Source

View on FDA website ↗

Reason for Recall

This recall was initiated due to a customer complaint which reported that while peeling off the Tyvek lid on the blister pack, very little effort was required to remove it and this could lead to contamination of the device.

Distribution

Outside the US to Austria, Belgium, and Germany

Lot / Code Info

REF 154600, LOT 2272736

Root Cause

Packaging

Action Taken

Biomet sent a "FIELD SAFETY NOTICE" dated April 21, 2011, to all affected accounts. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product, locate and remove from inventory and quarantine pending return to their Bioment distributor. Customers were also instructed to complete and return the attached "Fax Back Response Form" to their local Biomet distributor. For questions customers should contact their local Biomet Contact.