FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Biomet Orthopedics DCM AGC Molded Tibial Component, 12 mm thick x 80 mm, UHMWPE/CO-CR-MO alloy, sterile; REF 155116.
- Recall number
- Z-0077-2008
- Recalling firm
- Biomet, Inc.
- Product
- Biomet Orthopedics DCM AGC Molded Tibial Component, 12 mm thick x 80 mm, UHMWPE/CO-CR-MO alloy, sterile; REF 155116.
- Status
- Terminated
- Initiated
- 2007-07-24
- Posted
- 2007-10-31
- Terminated
- 2008-07-24
- Reason
- Incorrect Product -- Mislabeled as to size; a 18 mm x 65 mm tibula implant is enclosed in a package labeled as 12 mm x 80 mm.
- Root cause
- Labeling mix-ups
- Action
- The firm notified distributor by phone on or about 7/24/07 and followed up with an Urgent Medical Device Recall Notice/Letter dated 8/31/07. The letter requested that the product be discontinued and returned to Biomet.
- Quantity
- 1
- Distribution
- Class II Recall - Worldwide Distribution --- USA including states of IA, SD, and countries of Brazil and Chile.
- Lot, serial or model codes
- Lot 918930; exp. 2012-02.
- 510(k) numbers
- ["K921182"]
- 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