Z-0397-2016Class II

IBS - Osteosynthesis screws for bone fixation Model S25 ST014

Name: Z-0397-2016 IBS - Osteosynthesis screws for bone fixation Model S25 ST014
Creator: In2Bones, SAS
Published: 2015-11-18
License: https://open.fda.gov/license/

In2Bones SAS / initiated 2015-11-18 / Terminated / root cause: manufacturing process

FDA source

In2Bones, SAS began a recall of IBS - Osteosynthesis screws for bone fixation Model S25 ST014 on 2015-11-18. FDA classified it as Class II and gives the reason as "One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0397-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-18
Posted: 2015-12-09
Terminated: 2016-08-19
Recalling firm: In2Bones SAS
Product: IBS - Osteosynthesis screws for bone fixation Model S25 ST014.
Product code: HWC Screw, Fixation, Bone
Reason for recall: One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head.
Root cause tag: manufacturing process
FDA 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:[email protected].
Quantity in commerce: 20 units
Distribution: US Distribution to the state of :TN
Product codes and lots: 1509058

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0397-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0397-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-09

Product code HWC

K131920Class IIStabilization ScrewIn2bones Sas / cleared 2014-05-01

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)