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U.S. Department of Health and Human Services

Class 2 Device Recall 2.5 Pin Pouch

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  Class 2 Device Recall 2.5 Pin Pouch see related information
Date Initiated by Firm October 02, 2019
Create Date November 12, 2019
Recall Status1 Terminated 3 on May 19, 2023
Recall Number Z-0361-2020
Recall Event ID 84040
Product Classification Pin, fixation, smooth, metallic - Product Code NDL
Product 2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the Vantage Total Ankle System - Product Usage: To assist the surgeon in the implantation of Vantage Total Ankle System components according to a conventional technique for total ankle replacement. These instruments are single-use, provided sterile, and intended for transient use.
Code Information Catalog Number: 351-90-22; UDI Number: 10885862567529; Expiration Date: 08/28/2028; Serial Numbers (6189213, 6189221, 6189222, 6189223, 6189228, 6189229, 6189249, 6189262, 6189273); Packaging Lots Numbers (49079322, 49079321); Manufacturing Lot Number:19030412
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact
352-377-1140
Manufacturer Reason
for Recall		 Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended.
FDA Determined
Cause 2		 Error in labeling
Action Exactech notified customers on about 10/02/2019, via "URGENT MEDICAL DEVICE RECALL" letter. Customers were informed that the 2.4mm x 2.5" Fluted Pin Pouch was found to contain a single pin rather than four (4) as labeled. Instructions included to immediately cease distribution or use of the affected product, provide the information to customers if further distributed, identify and quarantine any of the affected devices in inventory, and complete and return the provided Recall Acknowledgement Form and Recall Inventory Response Form to Exactech via email to recalls@exac.com.
Quantity in Commerce 9 units
Distribution US Nationwide distribution in the states of GA, NY, OH, VA.
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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