FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Arthrotek brand Lactoscrew instruments 3.5 mm drill bit, stainless steel; ref. 905585.
- Recall number
- Z-0329-06
- Recalling firm
- Biomet, Inc.
- Product
- Arthrotek brand Lactoscrew instruments 3.5 mm drill bit, stainless steel; ref. 905585.
- Status
- Terminated
- Initiated
- 2005-11-10
- Posted
- 2005-12-28
- Terminated
- 2006-01-12
- Reason
- The bit may bend or fracture during use.
- Root cause
- Other
- Action
- Consignees were notified to return the product via letter dated 11/10/05.
- Quantity
- 46
- Distribution
- Nationwide, Australia, Belgium, Columbia, Finland, Israel, Poland and United Kingdom.
- Lot, serial or model codes
- Lots 044250, 134170, 781690, 781700, 838920, 914620 and 914630.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GFG
- 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