Wright Medical Hardware Removal Kit Recalled for Missing Drivers
Wright Medical Technology is recalling 66 hardware removal kits because they lack the specific drivers needed to remove Dart-Fire 2.5 and 3.0mm 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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a functional defect (missing components) rather than a direct safety threat like contamination or structural failure, fitting the criteria for a moderate severity voluntary recall.
Plain-English summary
Wright Medical Technology, Inc. is recalling 66 units of the Hardware Removal Kit, Part Number 1985KIT1. The recall was initiated because the kits do not include the specific drivers required to remove Dart-Fire 2.5 and 3.0mm Headless screws. The product is a multiple use, non-sterile instrument designed to facilitate the removal of plates and screws used in foot and ankle procedures.
The affected kits were 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 specific lot codes involved in this recall are 01 through 64, 66, and 67.
Healthcare providers and consumers should stop using the affected hardware removal kits. Wright Medical Technology is the recalling firm responsible for this action.
The recalled product
- 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…
- Manufacturer
- Wright Medical Technology, Inc.
- Hazard
- Affected units
- 66
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 (2)
- Lot Codes: 01 through 64
- 66 and 67
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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