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.
FDA Recall Z-2698-2011 · Posted 2011-06-29
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Recalling FirmBiomet U.K., Ltd.
Recall StatusTerminated
Product CodeHRY
Date Initiated2011-04-22
Date Terminated2011-08-03
Product Quantity12 devices
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.
Firm Action
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.
Root Cause
Packaging
Distribution Pattern
Outside the US to Austria, Belgium, and Germany
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.
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