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.
FDA Recall Z-2796-2020 · Posted None
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Recalling FirmWright Medical Technology, Inc.
Recall StatusTerminated
Product CodeLRO
Date Initiated2020-07-28
Date Terminated2022-11-16
Product Quantity66 kits
Reason for Recall
Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws.
Firm 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.
Root Cause
Device Design
Distribution Pattern
US Nationwide distribution including in the states of CO, TX, OR, KX, SC, CA, AR, NJ, UT, VA, MO, NC, FL, IL.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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