NEOSTEO: Medical Device Recall in 2021 - (Recall #: Z-2236-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 3, 2020

Date Posted: August 18, 2021

Recall Number: Z-2236-2021

Event ID: 88307

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.

Status: Terminated

Product Quantity: 25

Code Information:

Lot: 243-20

Distribution Pattern:

US Nationwide distribution in the state of New Jersey.

Voluntary or Mandated:

Voluntary: Firm initiated