NEOSTEO Recall 88307
Description: Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.
NEOSTEO Recall 88307 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2236-2021 |
| Event ID | 88307 |
| Event Description | Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of New Jersey. |
| Quantity | 25 |
| Recall 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. |
| Device Classification | 20210818 |
| Device Code Info | Lot: 243-20 |
| Center Classification Date | 20210809 |
| Recall Initiation Date | 20201103 |
| Recalling Firm | NEOSTEO |
| Initial Notification | Letter |
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