Wright Medical Technology, Inc. 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Wright Medical Technology, Inc.
Lot Codes / Batch Numbers
Lot Codes: 01 through 64, 66 and 67
Products Sold
Lot Codes: 01 through 64, 66 and 67
Wright Medical Technology, Inc. is recalling Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medical hardware removal kit due to Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026