FDA Medical Device Recalls (openFDA)
In2Bones, SAS: IBS - Osteosynthesis screws for bone fixation Model S25 ST014.
- Recall number
- Z-0397-2016
- Recalling firm
- In2Bones, SAS
- Product
- IBS - Osteosynthesis screws for bone fixation Model S25 ST014.
- Status
- Terminated
- Initiated
- 2015-11-18
- Posted
- 2015-12-09
- Terminated
- 2016-08-19
- Reason
- One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head.
- Root cause
- Nonconforming Material/Component
- Action
- IN2Bones - USA sent an Field Safety Corrective Action Medical Device Batch Recall letter dated November 17, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Recommended actions : We therefore you to follow the instructions here below: 1. Identify all I.B.screws with the batches subject of this recall that might still be in your inventory and quarantine them 2. Inform and distribute this Recall Notification to all relevant persons within your organization 3. To distributors only : Identify all I.B.screws with the batches subject of this recall that were delivered to your customers, and if relevant instruct them to also follow these instructions (identification and quarantine) 4. Fill in and return the fax back form enclosed. With this form, you will certify that you have received this Recall Notification and intend to, comply with the recommendations listed.This fax back form will enable ln2Bones to conduct effectiveness checks. For any question,plea1se contact our Quality and Regulatory Affairs team at: +33 4 72 29 26 26/ +33 7 6188 44 30 or by email:qualite@in2bones.com.
- Quantity
- 20 units
- Distribution
- US Distribution to the state of :TN
- Lot, serial or model codes
- 1509058
- 510(k) numbers
- ["K131920"]
- 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