FDA Device recall Z-2236-2021
Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery
- FDA Device
- Class II
- terminated
- Published 2021-08-18
On 2021-08-18 the FDA classified a Class II recall of Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery by Neosteo, citing 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, poten….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2236-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-03 |
| Published | 2021-08-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Neosteo |
| Distribution | US |
Product
Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.
Reason
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.
Identifiers
| code_info | Lot: 243-20 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2236-2021%22
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