Use caution Medical device recall · FDA · Published November 3, 2020

Neosteo 1.9mm Drill Bit Recall: Corrosion Risk in Orthopedic Surgery

Neosteo recalls 1.9mm cannulated drill bits with AO QC system (lot 243-20) due to corrosion traces that may cause inflammation, pain, or allergic reactions during orthopedic surgery.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2236-2021Medical device Neosteo ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmNEOSTEO2 rue Robert Schuman · Reze, France

✎ GovInfoNow plain-language explainer

Neosteo is recalling 1.9mm cannulated drill bits used in orthopedic surgery because corrosion traces could cause inflammation, pain, or allergic reactions during surgery. This affects surgeons and medical staff who use these tools for bone procedures. Read more at govinfonow.com/recall/63990-neosteo-1-9mm-drill-bit-recall-corrosion-risk-in-orthopedic.

Source Summary by GovInfoNow · govinfonow.com/recall/63990-neosteo-1-9mm-drill-bit-recall-corrosion-risk-in-orthopedic · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2236-2021

Cite this page

“Neosteo 1.9mm Drill Bit Recall: Corrosion Risk in Orthopedic Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63990-neosteo-1-9mm-drill-bit-recall-corrosion-risk-in-orthopedic. Based on FDA recall #Z-2236-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2236-2021%22&limit=1).

The FDA announced on November 3, 2020, that Neosteo is recalling Cannulated graduated drill bits due to traces of corrosion that could lead to inflammation or adverse tissue reactions. Owners should contact the company for a remedy.

How to tell if you have it

Brand: Neosteo
Product: Cannulated graduated drill bit 1.9 mm diameter, with AO QC system
REF: INS-114
Lot: 243-20

The hazard

Traces of corrosion on the laser marking were detected on the cannulated graduated drill bit, which could lead to the emission of wear or corrosion particles in the operated area. This potentially leads to risks including inflammation, pain, allergy, and adverse tissue reaction.

Context

GovInfoNow's records show other recent recalls include Surgify Halo 40mm Drill (2026-04-30), Surgify Halo 3.0mm Drill (2026-04-30), and Surgify Halo 5.4mm Drill (2026-04-30).

How to tell if you have this one

Check for the Neosteo brand, 1.9mm diameter, with AO QC system (reference INS-114), and lot number 243-20. These drill bits are used in orthopedic surgery for bone procedures.

Brand
Neosteo
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Corrosion Traces
Inspect the drill bit for visible corrosion or wear marks, especially on the shaft where it connects to the surgical motor.
Contact Neosteo for Replacement
Reach out to Neosteo directly to request a replacement drill bit if corrosion is found or if you have the specific lot number 243-20.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution in the state of New Jersey.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 13 months after the firm started it.

Nov 3, 2020Firm started the recall
Aug 9, 2021FDA classified it Class II
Aug 18, 2021Published in FDA’s Enforcement Report
Dec 6, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/63990-neosteo-1-9mm-drill-bit-recall-corrosion-risk-in-orthopedic">Neosteo 1.9mm Drill Bit Recall: Corrosion Risk in Orthopedic Surgery (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2236-2021 (November 3, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2236-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.