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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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…
- Manufacturer
- Wright Medical Technology, Inc.
- Hazard
- 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
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.
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