Recall Z-2236-2021 ยท HTW Bit, Drill
NEOSTEO
Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.
| Date | Nov 3, 2020 |
| Status | Terminated |
| 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 count |
| 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 add |
| Quantity | 25 |
| Distribution | US Nationwide distribution in the state of New Jersey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.