FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Biomet CC Cruciate Tibial Tray, 67 mm.; Product No. 141232, Biomet, Inc., Warsaw, IN 46581
- Recall number
- Z-0706-2008
- Recalling firm
- Biomet, Inc.
- Product
- Biomet CC Cruciate Tibial Tray, 67 mm.; Product No. 141232, Biomet, Inc., Warsaw, IN 46581
- Status
- Terminated
- Initiated
- 2007-12-12
- Posted
- 2008-01-31
- Terminated
- 2008-06-11
- Reason
- Mislabeled as to size: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa.
- Root cause
- Packaging process control
- Action
- Consignees were notified via an Urgent Medical Device Recall Notice dated 12/12/07 to cease use of the product and to return it.
- Quantity
- 8
- Distribution
- Worldwide: USA including states of Georgia, Idaho, Indiana, Missouri, Ohio, and Virginia and country of Turkey.
- Lot, serial or model codes
- Lot Number: 448530.
- 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
- 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