Reported Aug 9, 2017 · Terminated
Non-Locking screws in the following lengths
In2Bones, SAS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: In2Bones, SAS · 28 Chemin du petit Bois · Ecully, N/A · N/A
Is this the product you have?
Non-Locking screws in the following lengths
7 of 7 products
| Model / number | Product as published |
|---|---|
W27 | ST010 (b) NEO(R) 0.27 - 12 mm |
W27 | ST012 (c) DRP 0.27 - 12 mm |
W27 | ST012 (d) NEO(R) 0.27 - 14 mm |
W27 | ST014 (e) NEO(R) 0.27 - 16 mm |
W27 | ST016 (f) NEO(R) 0.27 - 18 mm |
W27 | ST018 (f) DRP 0.27 - 18 mm |
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 |
- Lot codes and dates
- All batch numbers
- Amount recalled
- 287 screws
Where it was sold
Why it was recalled
The firm received several customer complaints reporting some perioperative breakages of NE0411 Non-Locking screws when inserting the screw into the radius diaphysis
This product could cause temporary or reversible health problems — stop using it.
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