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U.S. Department of Health and Human Services

Class 2 Device Recall Threaded Offset Cup Impactor

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  Class 2 Device Recall Threaded Offset Cup Impactor see related information
Date Initiated by Firm July 24, 2019
Date Posted September 10, 2019
Recall Status1 Open3, Classified
Recall Number Z-2499-2019
Recall Event ID 83520
Product Classification Impactor - Product Code HWA
Product Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
Code Information Catalog Number 181-02-01, Lot Numbers 103071001, UDI Number 10885862520623.  Expansion on 09/09/2019 to include Lot Number 8182001
Recalling Firm/
Manufacturer
Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact Jean-Philippe Gobeil-Jobidon
352-377-1140
Manufacturer Reason
for Recall
The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Exactech notified customers on about 07/24/2019 via "URGENT MEDICAL DEVICE RECALL" letter. Instructions included to immediately cease distribution or use of the affected devices, provide the information to customers if further distributed, identify and quarantine any affected devices, and complete and return the provided Recall Acknowledgement Form and Recall Inventory Response Form to Exactech via email at recalls@exac.com. On 09/09/2019, Exactech expanded the recall to include an additional lot. Customers were notified of the expansion on about 09/09/2019.
Quantity in Commerce 22 devices
Distribution US distribution to AR, CA, FL, IL, IN, NY, SC, TX.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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