Z-2236-2021Class II

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

Name: Z-2236-2021 Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery
Creator: Neosteo
Published: 2020-11-03
License: https://open.fda.gov/license/

Neosteo / initiated 2020-11-03 / Terminated / root cause: manufacturing process

FDA source

NEOSTEO began a recall of Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery on 2020-11-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2236-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-03
Posted: 2021-08-09
Terminated: 2021-12-06
Recalling firm: Neosteo
Product: Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.
Product code: HTW Bit, Drill
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 11/03/2020, a recall notice was emailed. Their customer was asked to do the following: 1 - Identify and quarantine all affected devices present in your establishment. 2 - Circulate this safety notice to all concerned. 3 - Complete return the customer response form . 4 - In the event that you have distributed the products concerned to another organization yourself, circulate this notice to them and then return the response forms to us once completed. 5 - Return the devices to us (or contact us to organize the removal) by attaching a copy of the attached customer response form. For any additional questions regarding this recall, please contact Anne-Ccile Grandremy, Quality and Regulatory Affairs Manager on 06 59 08 60 56 or by email [email protected].
Quantity in commerce: 25
Distribution: US Nationwide distribution in the state of New Jersey.
Product codes and lots: Lot: 243-20

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2236-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2236-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-09

Product code HTW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)