# FDA recall Z-2236-2021

> **NEOSTEO** · Class II · device recall initiated 2020-11-03.

## Product

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

US Nationwide distribution in the state of New Jersey.

## Key facts

- **Recall number:** Z-2236-2021
- **Recalling firm:** NEOSTEO
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-03
- **Report date:** 2021-08-18
- **Termination date:** 2021-12-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Reze, N/A, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2236-2021

## Citation

> AI Analytics. FDA recall Z-2236-2021. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-2236-2021. Source: US FDA. Licensed CC0.

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