FDA Medical Device Recalls (openFDA)
Biomet U.K., Ltd.: 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.
- Recall number
- Z-2698-2011
- 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.
- Status
- Terminated
- Initiated
- 2011-04-22
- Posted
- 2011-06-29
- Terminated
- 2011-08-03
- Reason
- 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
- 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
- 12 devices
- Distribution
- Outside the US to Austria, Belgium, and Germany
- Lot, serial or model codes
- REF 154600, LOT 2272736
- 510(k) numbers
- ["K011138"]
- PMA numbers
- ["P010014"]
- Product code
- HRY
- Firm FEI
- 3002806535
- Firm city
- South Wales
- Firm state
- Bridgend
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28