Recall Z-0397-2016 ยท HWC Screw, Fixation, Bone
In2Bones, SAS
IBS - Osteosynthesis screws for bone fixation Model S25 ST014.
| Date | Dec 9, 2015 (initiated Nov 18, 2015) |
| Status | Terminated |
| 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.screw |
| Quantity | 20 units |
| Distribution | US Distribution to the state of :TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131920 | STABILIZATION SCREW In2bones Sas, May 1, 2014 |