FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Biomet K-Wire/Trocar Point, both ends/Dia. 045, length: 9 in., certified stainless steel, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 35-351534. Internal fixation devices intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. The devices can also be used as instrument accessories to stabilize cut blocks and can serve as guide wires while using reamers.
- Recall number
- Z-0367-2010
- Recalling firm
- Biomet, Inc.
- Product
- Biomet K-Wire/Trocar Point, both ends/Dia. 045, length: 9 in., certified stainless steel, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 35-351534. Internal fixation devices intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. The devices can also be used as instrument accessories to stabilize cut blocks and can serve as guide wires while using reamers.
- Status
- Terminated
- Initiated
- 2009-08-06
- Posted
- 2009-11-19
- Terminated
- 2010-10-06
- Reason
- Packages labeled as having a .045 inch diameter trocar point actually contain a diamond point with a diameter of .062 inches.
- Root cause
- Process control
- Action
- An "Urgent Medical Device Recall Notice" dated August 6, 2009 was issued to consignees. The letter described the affected product, issue and actions for consignees. Customers were instructed to complete and return the "FAX back Response Form" (fax number 1-574-372-1683) and all affected product in inventory to Biomet Orthopedics. Direct questions related to the recall notification by calling at 1-800-348- 9500 or 1-574-372-3983, Monday through Friday, 8AM to 5PM.
- Quantity
- 19
- Distribution
- United States (Florida and Pennsylvania).
- Lot, serial or model codes
- Lot Number 087190.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FZX
- 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