—#182373

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.

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot Codes: 01 through 64, 66 and 67

Why it was recalled

Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Wright Medical Technology, Inc.
Address: 1023 Cherry Rd, Memphis, Tennessee 38117-5423

Distribution

Distribution pattern: US Nationwide distribution including in the states of CO, TX, OR, KX, SC, CA, AR, NJ, UT, VA, MO, NC, FL, IL.

Timeline

Recall initiated: 2020-07-28
Terminated: 2022-11-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #182373. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.