NEOSTEO 2 rue Robert Schuman Reze France Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.