U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Plate, fixation, bone - Product Code HRS
원인
The firm received several customer complaints reporting some perioperative breakages of ne0411 non-locking
screws when inserting the screw into the radius diaphysis.
조치
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.
Worldwide Diribution - US including Tennessee; Foreign - Italy, Portugal, Spain, Switzerland, UK, and France
제품 설명
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 extra-articular fractures of the distal radius and reconstruction of the distal radius. It is composed of a NEOVIEW" plate in PEEK and NE0411 screws in Ti6Al4V that are available in Locking or Non-Locking versions. The NEOVIEW411 Screw Set consists of a standard set of NE0411 screws with different lengths suitable for the implantation of a NEOVIEW9 plate for an average anatomy