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U.S. Department of Health and Human Services

Class 2 Device Recall KWire

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 Class 2 Device Recall KWiresee related information
Date Initiated by FirmSeptember 10, 2019
Create DateOctober 21, 2019
Recall Status1 Terminated 3 on May 01, 2023
Recall NumberZ-0168-2020
Recall Event ID 83855
Product Classification Wire, surgical - Product Code LRN
ProductErgo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components according to a conventional technique for total shoulder replacement. The wire is single-use, provided sterile, and intended for transient use.
Code Information Catalog Number: 321-52-06, All Serial Numbers
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information ContactPriscilla Bennet Jones
352-377-1140
Manufacturer Reason
for Recall		Potential for the wire to fracture at the threads and remain in the glenoid.
FDA Determined
Cause 2		Under Investigation by firm
ActionExactech notified customers of the recall on about 09/10/2019, via "URGENT MEDICAL DEVICE RECALL" letter. Customers were informed that Exactech had received reports of the 3.2mm K-Wire fracturing at the threads and remaining in the glenoid. Instructions included to immediately cease distribution of or use of the product, provide the recall information to accounts that may have the affected product in their possession, identify and quarantine any affected products in inventory, and complete and return the attached Recall Acknowledgement Form and Recall Inventory Response form to Exactech via email at recalls@exac.com.
Quantity in Commerce158 devices
DistributionUS Nationwide including the states of AR, AZ, CA, CO, FL, IL, IN, KS, LA, MN, NY, NY, OH, SC, TN, TX, VA, WA.
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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