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Class 2 Device Recall Drill Bit, Cannulated, 5.0 mm |
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| Date Initiated by Firm |
February 24, 2021 |
| Create Date |
March 26, 2021 |
| Recall Status1 |
Terminated 3 on May 02, 2023 |
| Recall Number |
Z-1310-2021 |
| Recall Event ID |
87481 |
| Product Classification |
Bit, drill - Product Code HTW
|
| Product |
Drill 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 Contact |
Arthrex Product Surveillance Dept.
866-267-9138
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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 |
| Action |
Consignees 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 Commerce |
9 units |
| Distribution |
US Nationwide distribution in the states of Ohio, Oregon, Tennessee, Texas. |
| Total Product Life Cycle |
TPLC Device Report
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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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