Z-2698-2011

Oxford Femoral Knee System REF 154600, LOT 2272736, WARNING DO NOT RESTERILIZE, STERILE UNLESS PACK DAMAGED...

Name: Z-2698-2011 Oxford Femoral Knee System REF 154600, LOT 2272736, WARNING DO NOT RESTERILIZE, STERILE UNLESS PACK DAMAGED...
Creator: Biomet U.K., Ltd.
Published: 2011-04-22
License: https://open.fda.gov/license/

Biomet U.K., Ltd. / initiated 2011-04-22 / Terminated / root cause: packaging

FDA source

Biomet U.K., Ltd. began a recall of 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... on 2011-04-22. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2698-2011
Status: Terminated
Initiated: 2011-04-22
Posted: 2011-06-29
Terminated: 2011-08-03
Recalling firm: Biomet U.K., Ltd.
Product: 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.
Product code: HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
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.
Root cause tag: packaging
FDA root cause: Packaging
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.
Quantity in commerce: 12 devices
Distribution: Outside the US to Austria, Belgium, and Germany
Product codes and lots: REF 154600, LOT 2272736

Product code HRY

K011138Class IIOxford Unicompartmental Knee Femoral ComponentBiomet, Inc. / cleared 2001-07-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)