FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Biomet Interlok 67 mm Fixed Cruciate Tibial Plate with Locking Bar; CO-CR-MO/TI 6AL 4V Alloy; Product Number/REF 141232, Biomet Orthopedics, Inc., Warsaw, IN 46582
- Recall number
- Z-0255-2008
- Recalling firm
- Biomet, Inc.
- Product
- Biomet Interlok 67 mm Fixed Cruciate Tibial Plate with Locking Bar; CO-CR-MO/TI 6AL 4V Alloy; Product Number/REF 141232, Biomet Orthopedics, Inc., Warsaw, IN 46582
- Status
- Terminated
- Initiated
- 2007-09-18
- Posted
- 2007-11-24
- Terminated
- 2008-06-04
- Reason
- Mislabeled as to size: the package actaully contained a 71 mm tray.
- Root cause
- Labeling mix-ups
- Action
- Consignees were notified via letter dated 9/18/07 to discontinue use of the product and to return it to the firm.
- Quantity
- 7
- Distribution
- Nationwide : Distributors in Georgia, Kentucky, Texas and Washington.
- Lot, serial or model codes
- Lot 626520.
- 510(k) numbers
- ["K915132"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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