Oxford Femoral Knee System REF 154600, LOT 2272736, WARNING DO NOT RESTERILIZE, STERILE UNLESS PACK DAMAGED, BIOMET UK L
FDA device recall Z-2698-2011 · posted 2011-06-29 · Terminated
Recall details
- Recalling firm
- Biomet U.K., Ltd.
- 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.
- 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.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- HRY
- Quantity affected
- 12 devices
- Distribution
- Outside the US to Austria, Belgium, and Germany
- Date initiated
- 2011-04-22
- Date posted
- 2011-06-29
- Date terminated
- 2011-08-03
- Location
- South Wales, Bridgend, United Kingdom
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT (K011138) | Biomet, Inc. | 2001-07-10 |