Reported Aug 18, 2021 · Terminated
Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.
Neosteo
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: NEOSTEO · 2 rue Robert Schuman · Reze, N/A · N/A
Is this the product you have?
- Cannulated graduated drill bit 1.9 mm diameter, with AO QC system
- REFINS-114 for use in orthopedic surgery
- Lot codes and dates
- Lot243-20
- Amount recalled
- 25
Where it was sold
- Nationwide
- NJ
Why it 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.
This product could cause temporary or reversible health problems — stop using it.
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