Cannulated graduated drill bit 1 — Class II medical device recall Z-2236-2021
Terminated recall by NEOSTEO, reported 2021-08-18, distributed nationwide. Traces of corrosion on the laser marking was detected on cannulated graduated drill bit, which could lead to t
| Recall number | Z-2236-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NEOSTEO, Reze, N/A, France |
| Recall initiated | 2020-11-03 |
| Classified | 2021-08-09 |
| Reported by FDA | 2021-08-18 |
| Terminated | 2021-12-06 |
| Distributed | Nationwide (US) |
| Quantity | 25 |
| Lot numbers | 243-20 |
| Model numbers | INS-114 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2236-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.