Nextremity Solutions Recalls InCore Lapidus Disposable Kits Due to Drill Bushing Defect
Nextremity Solutions is recalling 111 units of the InCore Lapidus Disposable Kit 28mm Left 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, but the source text describes a functional defect that prevents procedure completion rather than a direct risk of serious injury or death, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Nextremity Solutions is recalling 111 units of the InCore Lapidus Disposable Kit 28mm Left (Part Number: IC-LAP-28L). 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 prevent the drill bit from passing through the bushing, resulting in the surgeon's inability 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 168B29619A and the UDI is 00817701020868. Healthcare providers should stop using the affected product and contact Nextremity Solutions for further instructions.
The recalled product
- Product
- InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.
- Manufacturer
- Nextremity Solutions
- Affected units
- 111
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: 168B29619A UDI: 00817701020868
Distribution
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.
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