Z-2236-2021 Class II Terminated

Recalled by NEOSTEO — Reze, N/A

Recall Details

Product Type
Devices
Report Date
August 18, 2021
Initiation Date
November 3, 2020
Termination Date
December 6, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
25

Product Description

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

Reason for Recall

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 Pattern

US Nationwide distribution in the state of New Jersey.

Code Information

Lot: 243-20