Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1501-2021·Announced 2021-05-05

Nextremity Solutions Recalls InCore Lapidus Disposable Kits Due to Drill Bushing Defect

Nextremity Solutions is recalling 123 units of InCore Lapidus Disposable Kits because a drill bushing defect may prevent surgeons from completing the intended procedure.

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 describes a procedural failure (inability to complete surgery) rather than a direct physical injury or death, fitting the criteria for a moderate severity recall.

Plain-English summary

Nextremity Solutions is recalling 123 units of the InCore Lapidus Disposable Kit 28mm Right (Part Number: IC-LAP-28R). The product is a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.

The recall was initiated because the product could potentially contain an undersized inner diameter in the 40mm drill bushing. This defect may result in the drill bit not passing through the drill bushing, which could cause the surgeon to be unable to complete the surgical procedure as intended.

The affected units were distributed to Alabama, Alaska, California, Iowa, Illinois, Indiana, Kentucky, Maryland, Michigan, New Jersey, New York, Oregon, Pennsylvania, South Carolina, Texas, and Virginia. The specific lot number is 168B29619B and the UDI is 00817701020875. Healthcare providers and patients should contact Nextremity Solutions for further instructions regarding the recall.

The recalled product

Product: InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.
Manufacturer: Nextremity Solutions
Category: Medical Device — Orthopedic Implant
Hazard: manufacturing-defect
procedural-failure
Affected units: 123

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)

Lot Number: 168B29619B UDI: 00817701020875

Distribution

Distributed in 16 states:

Part of a larger recall action

This product is one of 2 recalled by Nextremity Solutions 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 →

Same manufacturer · Nextremity Solutions

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Same hazard · manufacturing defect