FDA Medical Device Recalls (openFDA)
XTANT Medical: Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591
- Recall number
- Z-2500-2020
- Recalling firm
- XTANT Medical
- Product
- Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591
- Status
- Terminated
- Initiated
- 2020-05-12
- Posted
- not on file
- Terminated
- 2021-03-19
- Reason
- The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld.
- Root cause
- Process design
- Action
- On May 12, 2020 a customer letter (in an envelope marked URGENT) was Federal Expressed priority overnight-signature required to the three customers who received the affected devices. On May 19, 2020, an additional customer letter (in an envelope marked URGENT) was Federal Expressed priority overnight-signature required to one of the three affected customers.
- Quantity
- 4 units
- Distribution
- AZ, TX and WV.
- Lot, serial or model codes
- LOT: XS1920458A
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWA
- Firm FEI
- 3005031160
- Firm city
- Belgrade
- Firm state
- MT
- 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