FDA Medical Device Recalls (openFDA)
NEOSTEO: Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.
- Recall number
- Z-2236-2021
- Recalling firm
- NEOSTEO
- Product
- Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.
- Status
- Terminated
- Initiated
- 2020-11-03
- Posted
- not on file
- Terminated
- 2021-12-06
- 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.
- 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 acgrandremy@neosteo.com.
- Quantity
- 25
- Distribution
- US Nationwide distribution in the state of New Jersey.
- Lot, serial or model codes
- Lot: 243-20
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTW
- Firm FEI
- 3010580333
- Firm city
- Reze
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28