FDA Medical Device Recalls (openFDA)
In2Bones, SAS: DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant.
- Recall number
- Z-1318-2015
- Recalling firm
- In2Bones, SAS
- Product
- DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant.
- Status
- Terminated
- Initiated
- 2015-03-09
- Posted
- 2015-03-25
- Terminated
- 2016-05-19
- Reason
- Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.
- Root cause
- Nonconforming Material/Component
- Action
- The firm notified their sole consignee in the US by email on 03/09/2015 requesting the return of the product, and to notify his consignee(s) to quarantine the unused product.
- Quantity
- 35 units
- Distribution
- Distributed in the state of TN.
- Lot, serial or model codes
- Batch numbers: 1404032, 1412011
- 510(k) numbers
- ["K132912"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 3010470577
- Firm city
- Ecully
- Firm state
- not on file
- Firm country
- France
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