Z-2796-2020Class II

Hardware removal kit, Part Number 1985KIT1 -

Name: Z-2796-2020 Hardware removal kit, Part Number 1985KIT1 -
Creator: Wright Medical Technology, Inc.
Published: 2020-07-28
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2020-07-28 / Terminated / root cause: design

FDA source

Wright Medical Technology, Inc. began a recall of Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both plates and screws... on 2020-07-28. FDA classified it as Class II and gives the reason as "Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2796-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-28
Posted: 2020-08-13
Terminated: 2022-11-16
Recalling firm: Wright Medical Technology Inc
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.
Product code: LRO General Surgery Tray
Reason for recall: Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: Lot Codes: 01 through 64, 66 and 67

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2796-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2796-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-19	2020-08-13
Z-2797-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-19	2020-08-13

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)