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U.S. Department of Health and Human Services

Class 2 Device Recall Drill Bit, Cannulated, 5.0 mm

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 Class 2 Device Recall Drill Bit, Cannulated, 5.0 mmsee related information
Date Initiated by FirmFebruary 24, 2021
Create DateMarch 26, 2021
Recall Status1 Terminated 3 on May 02, 2023
Recall NumberZ-1310-2021
Recall Event ID 87481
Product Classification Bit, drill - Product Code HTW
ProductDrill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
Code Information Product Code AR-8770-02, Lot Number 032052
Recalling Firm/
Manufacturer
Arthrex, Inc.
1370 Creekside Blvd
Naples FL 34108-1945
For Additional Information ContactArthrex Product Surveillance Dept.
866-267-9138
Manufacturer Reason
for Recall
The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.
FDA Determined
Cause 2
Under Investigation by firm
ActionConsignees were notified via e-mail with URGENT: RECALL NOTIFICATION dated 02/23/2021. The letter identified affected product, reason for recall, and instructed consignee to immediately discontinue use, sale, and distribution of the product as well instructions for handling of affected product.
Quantity in Commerce9 units
DistributionUS Nationwide distribution in the states of Ohio, Oregon, Tennessee, Texas.
Total Product Life CycleTPLC 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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