Recall Z-0954-2017 ยท HRS Plate, Fixation, Bone
In2Bones, SAS
NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius
| Date | Jan 6, 2017 (initiated Dec 19, 2016) |
| Status | Terminated |
| Reason | Dimensional non-conformity of the thread on the screw head. |
| Root cause | Component design/selection |
| Action | IN2BONES en a Field Safety Corrective Action letter dated December 15, 2016, to the sole US distributor. The letter identified the product, the problem, and the action to be taken by the customer. We therefore recommend you to follow the instructions here below: 1. Identify all the devices 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 the devices with the batches subject of this recall that were delivered |
| Quantity | 26 units |
| Distribution | Worldwide Distribution - US TN only and Internationally to France and Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160995 | NEOVIEW Plating System In2bones Sas, Jun 10, 2016 |