NEOSTEO recalls Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.

Recall date

November 3, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2236-2021

FDA classification

Class II

Brand / firm

NEOSTEO

Sold / distributed

US Nationwide distribution in the state of New Jersey.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.