Recall record at a glance
| Official record | Z-0954-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | In2Bones, SAS |
| Report date | Jan 18, 2017 |
| Recall initiation date | Dec 19, 2016 |
| Quantity | 26 units |
| Location | Ecully, France |
Official product description
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
Why the product was recalled
Dimensional non-conformity of the thread on the screw head.
Distribution information
Worldwide Distribution - US TN only and Internationally to France and Switzerland
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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