Recall record at a glance
| Official record | Z-2236-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | NEOSTEO |
| Report date | Aug 18, 2021 |
| Recall initiation date | Nov 3, 2020 |
| Quantity | 25 |
| Location | Reze, N/A, France |
Official product description
Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.
Why the product was recalled
Traces of corrosion on the laser marking was detected on cannulated graduated drill bit, which could lead to the emission of wear / corrosion particles in the operated area, potentially leading to the following risks: Inflammation, pain, allergy, adverse tissue reaction. Device description: The drill bit is used to create the hole required for the introduction of the screw, it is suitable for Neosteo compression screws for cortical and spongy bone. Drilling depth can be read on the instrument. The shaft is coupled with the ¿4.5mm surgical motor using a AO ¿4.5mm male drive connexion. The countersink bit is coupled to a ¿1.0mm k-wire to ensure guiding while drilling. The instrument is packaged in a plastic sheath sealed by welding.
Distribution information
US Nationwide distribution in the state of New Jersey.
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: Letter.
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
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