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U.S. Department of Health and Human Services

Class 2 Device Recall Cannulated graduated drill bit 1.9mm with AO QC system

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  Class 2 Device Recall Cannulated graduated drill bit 1.9mm with AO QC system see related information
Date Initiated by Firm November 03, 2020
Create Date August 09, 2021
Recall Status1 Terminated 3 on December 06, 2021
Recall Number Z-2236-2021
Recall Event ID 88307
Product Classification Bit, drill - Product Code HTW
Product Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.
Code Information Lot: 243-20
Recalling Firm/
Manufacturer		 NEOSTEO
2 rue Robert Schuman
Reze France
Manufacturer 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.
FDA Determined
Cause 2		 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-C¿cile Grandremy, Quality and Regulatory Affairs Manager on 06 59 08 60 56 or by email acgrandremy@neosteo.com.
Quantity in Commerce 25
Distribution US Nationwide distribution in the state of New Jersey.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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