Recall Z-2869-2017 ยท HRS Plate, Fixation, Bone
In2Bones, SAS
Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W27 ST010 (b) NEO(R) 0.27 - 12 mm, REF W27 ST012 (c) DRP 0.27 - 12 mm, REF W27 ST012 (d) NEO(R) 0.27 - 14 mm, REF W27 ST014 (e) NEO(R) 0.27 - 16 mm, REF W27 ST016 (f) NEO(R) 0.27 - 18 mm, REF W27 ST018 (f) DRP 0.27 - 18 mm, REF W27 ST018 The NEOVIEW(R) Plating System is intended for fixation of intra-articular and ex
| Date | Jul 13, 2017 |
| Status | Terminated |
| Reason | The firm received several customer complaints reporting some perioperative breakages of NE0411 Non-Locking screws when inserting the screw into the radius diaphysis |
| Root cause | Device Design |
| Action | In2Bones sent a Field Safety Corrective Action letter dated July 13, 2017, to all affected customers. The consignee was directed to remove the products from distribution and return it to the recalling firm. Customers with questions were instructed to contact the Quality and Regulatory Affairs team at: +33 4 72 29 26 26/ +337 61 88 44 30 or by email: qualite@in2bones.com. |
| Quantity | 287 screws |
| Distribution | Worldwide Diribution - US including Tennessee; Foreign - Italy, Portugal, Spain, Switzerland, UK, and France |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160995 | NEOVIEW Plating System In2bones Sas, Jun 10, 2016 |