FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Compress Short Anchor Plug Holder, 13mm, Biomet Orthopedics, Inc., Warsaw, IN; REF CP461038. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery.
- Recall number
- Z-0521-2009
- Recalling firm
- Biomet, Inc.
- Product
- Compress Short Anchor Plug Holder, 13mm, Biomet Orthopedics, Inc., Warsaw, IN; REF CP461038. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery.
- Status
- Terminated
- Initiated
- 2008-07-18
- Posted
- 2009-01-07
- Terminated
- 2009-07-07
- Reason
- The set screw may not fully seat, which will prevent the handle from mating to the instrument during use.
- Root cause
- Process control
- Action
- Distributors were notified via an Urgent Medical Device Removal Notice, dated 7/18/08, which instructed them to locate and remove the instruments, carefully follow the instructions on the enclosed "FAX Back Response Form," fax a copy of the Response Form to 574-372-1683 prior to return of product, and to notify the hospital personnel via a copy of a recall letter. The letter also stated that the instruments would be reworked and returned to the distributors. Distributors are to confirm receipt of the notice by calling, 800-348-9500, ext 3983. Questions related to the notice should be directed to Mary Hardesty at 800-348-9500 or 574-372-3983.
- Quantity
- 41 of all products.
- Distribution
- Worldwide Distribution --- including USA and countries of Australia, Belgium and Finland.
- Lot, serial or model codes
- Lot 991680.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- 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