FDA Medical Device Recalls (openFDA)
Exactech, Inc.: Product is packed in plastic Tyvek packaging and is labeled as sterile as follows: ACUDRIVER FLEXIBLE OSTEOTOME FLAT NARROW REF: 400-40-14
- Recall number
- Z-0105-04
- Recalling firm
- Exactech, Inc.
- Product
- Product is packed in plastic Tyvek packaging and is labeled as sterile as follows: ACUDRIVER FLEXIBLE OSTEOTOME FLAT NARROW REF: 400-40-14
- Status
- Terminated
- Initiated
- 2003-06-17
- Posted
- 2003-11-11
- Terminated
- 2003-11-10
- Reason
- Instrument is excessively flexible making it unusable by the surgeon.
- Root cause
- Other
- Action
- The firm mailed a Recall Notification Letter to each account on June 17, 2003 asking them to cease distribution, return recalled product to them and to subrecall to any accounts they may have distributed to.
- Quantity
- 18
- Distribution
- Product was distributed to five distributors in the following states: LA, ME, NV, and GA.
- Lot, serial or model codes
- Lot 432978 Serial Numbers 0460912 to 0460954 Lot 433954 Serial Numbers 0471589 to 0482514 Lot 434846 Serial Numbers 0482490-0482514
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTZ
- Firm FEI
- 1038671
- Firm city
- Gainesville
- Firm state
- FL
- 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