FDA Medical Device Recalls (openFDA)
Arthrosurface, Inc.: Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The component in question is the hex driver (part number 2009-4001).
- Recall number
- Z-0475-2016
- Recalling firm
- Arthrosurface, Inc.
- Product
- Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The component in question is the hex driver (part number 2009-4001).
- Status
- Terminated
- Initiated
- 2014-06-09
- Posted
- 2015-12-23
- Terminated
- 2016-02-05
- Reason
- An oversight in the implementation of the design change record resulted in outdated components being shipped to customers. The component did not pass a half-cycle sterilization.
- Root cause
- Process change control
- Action
- The distributors were verbally notified, and replacement Rev F Hex Drivers sent to the locations of the kits. The kits had been moved in preparation for upcoming surgeries, but the Drivers were replaced prior to any additional surgery taking place. No affected product remains in the field. For further questions, please call (508) 520-3003.
- Quantity
- 3 units
- Distribution
- US Distribution to the states of : PA, WV and CA.
- Lot, serial or model codes
- SN 000242 SN 000244 SN 000246 SN 000247
- 510(k) numbers
- ["K132496"]
- PMA numbers
- not on file
- Product code
- LZJ
- Firm FEI
- 3004154314
- Firm city
- Franklin
- Firm state
- MA
- 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