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Oxford Femoral Knee System REF 154600, LOT 2272736, WARNING… recallZ-2698-2011 · Biomet U.K., Ltd. · initiated Apr 22, 2011

Terminated All recalls posted in June 2011

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Biomet U.K., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Packaging

What the company is doing

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.

Recall details

Recall number
Z-2698-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Apr 22, 2011
Posted by the FDA
Jun 29, 2011
Recalling firm
Biomet U.K., Ltd.
Quantity
12 devices
Product code
HRY
FDA submissions
K011138, P010014
Distribution
Outside the US to Austria, Belgium, and Germany

Product description

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.

Code information (models, lots, serial numbers)

REF 154600, LOT 2272736

Other devices under the same FDA submission

91 devices cleared under K011138, P010014 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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