The Recall Desk
ModerateFDA (Devices)·Z-2797-2020·Announced 2020-08-19

Wright Medical Screw Removal Case Assembly Recalled for Missing Drivers

Wright Medical Technology is recalling 9 units of the Screw Removal Case Assembly because the kits do not include drivers required to remove specific headless screws.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a functional defect (missing components) rather than a direct safety risk like contamination or structural failure, fitting the criteria for a moderate severity score.

Plain-English summary

Wright Medical Technology, Inc. is recalling 9 units of the Screw Removal Case Assembly, Part Number 1985BASE. The recall is due to a defect where the hardware removal kits do not include the drivers necessary to remove Dart-Fire 2.5 and 3.0mm Headless screws.

The affected product is a multiple use, non-sterile instrument designed to facilitate the removal of plates and screws used in foot and ankle procedures. The kits are distributed nationwide in the United States, including in the states of Colorado, Texas, Oregon, Kentucky, South Carolina, California, Arkansas, New Jersey, Utah, Virginia, Missouri, North Carolina, and Illinois. The product is not lot coded.

Healthcare facilities and consumers who possess this product should stop using it and contact Wright Medical Technology, Inc. for instructions on how to return the product or obtain a replacement.

The recalled product

Product
Screw Removal Case Assembly, Part Number 1985BASE - 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 a
Affected units
9

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • product is not lot coded

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Wright Medical Technology, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →