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U.S. Department of Health and Human Services

Class 2 Device Recall Hardware removal kit

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  Class 2 Device Recall Hardware removal kit see related information
Date Initiated by Firm July 28, 2020
Create Date August 13, 2020
Recall Status1 Terminated 3 on November 16, 2022
Recall Number Z-2796-2020
Recall Event ID 85982
Product Classification General surgery tray - Product Code LRO
Product Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both plates and screws used in foot and ankle procedures. Along with a complete range of drivers, the kit also features driver handles and a range of k-wires to assist in removal of cannulated screws. This product is a multiple use, non-sterile instrument.
Code Information Lot Codes: 01 through 64, 66 and 67
Recalling Firm/
Manufacturer		 Wright Medical Technology, Inc.
1023 Cherry Rd
Memphis TN 38117-5423
For Additional Information Contact Kevin C. Smith
901-867-9971
Manufacturer Reason
for Recall		 Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws.
FDA Determined
Cause 2		 Device Design
Action Wright disseminated the notices by Fed Ex and email on 07/28/2020. The notices requested the following actions: " Cease using the screw and driver combinations: Dart-Fire 2.5mm Headless Screw with HCS-056-25  1.5 Hex Driver and Dart-Fire 3.0mm Headless Screw and 44112001  2.0 Hex Driver " Disseminate this notice to all those who need to be aware within your organization. " Ensure that you have the right products for removal surgery through pre-operative planning and coordinating with your Wright Medical Representative. The firm will provide a new kit when available.
Quantity in Commerce 66 kits
Distribution US Nationwide distribution including in the states of CO, TX, OR, KX, SC, CA, AR, NJ, UT, VA, MO, NC, FL, IL.
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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