FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Biomet Orthopedics Apical Hole Plug, 3/8 - 24 threaded, TI-6AL-4V alloy, sterile; REF 123741, Biomet Orthopedics, Inc., Warsaw, IN 46581
- Recall number
- Z-0102-2008
- Recalling firm
- Biomet, Inc.
- Product
- Biomet Orthopedics Apical Hole Plug, 3/8 - 24 threaded, TI-6AL-4V alloy, sterile; REF 123741, Biomet Orthopedics, Inc., Warsaw, IN 46581
- Status
- Terminated
- Initiated
- 2007-08-09
- Posted
- 2007-10-27
- Terminated
- 2009-06-26
- Reason
- Incorrect or lack of threading: The plug component was manufactured incorrectly and does not fit with the screw hole as intended.
- Root cause
- Process control
- Action
- The distributor was notified via phone on or about 8/9/07 and by letter dated 8/31/07 and requested to return the product. Returns included subaccounts
- Quantity
- 5
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot 522080.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LPH
- 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