FDA Enforcement
Class II
Terminated
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.
Recall: Z-2796-2020
·
Reported August 19, 2020
Enforcement
- Recall Number
- Z-2796-2020
- Event ID
- 85982
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Wright Medical Technology, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- August 19, 2020
- Initiation Date
- July 28, 2020
- Classification Date
- August 13, 2020
- Termination Date
- November 16, 2022
- Address
- 1023 Cherry Rd, N/A, Memphis, TN, 38117-5423, United States
Description
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.
Reason
Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws.
Code Info
Lot Codes: 01 through 64, 66 and 67
Distribution
US Nationwide distribution including in the states of CO, TX, OR, KX, SC, CA, AR, NJ, UT, VA, MO, NC, FL, IL.
Quantity
66 kits