Nextremity Solutions recalls InCore Lapidus 28mm Left kit (part IC-LAP-28L) due to potential undersized drill bushing that may prevent surgical procedure completion.
Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended
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Contact the company
📍Recalling firmNextremity Solutions6210 N Buffalo St · Warsaw, IN 46580
✎ GovInfoNow plain-language explainer
Nextremity Solutions is recalling the InCore Lapidus Disposable Kit 28mm Left (part IC-L:28L) because it might have a drill bushing that's too small. This could prevent surgeons from completing the intended foot surgery. Affected users should contact the manufacturer for details. Read more at govinfonow.com/recall/62902-nextremity-incore-lapidus-kit-28mm-left-drill-bushing-size-risk.
“Nextremity InCore Lapidus Kit 28mm Left: Drill Bushing Size Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62902-nextremity-incore-lapidus-kit-28mm-left-drill-bushing-size-risk. Based on FDA recall #Z-1500-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1500-2021%22&limit=1).
Nextremity Solutions voluntarily recalled the InCore Lapidus Disposable Kit 28mm Left (Part Number: IC-LAP-28L) on March 26, 2021, according to the FDA. The device may contain an undersized drill bushing inner diameter that prevents the drill bit from passing through.
How to tell if you have it
Brand: Nextremity Solutions
Product: InCore Lapidus Disposable Kit 28mm Left
Part Number: IC-LAP-28L
Lot Number: 168B29619A
UDI: 00817701020868
Units: 111
The hazard
The product could potentially contain an undersized inner diameter of the 40mm drill bushing. This defect results in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended.
Context
GovInfoNow's records show Nextremity Solutions has had six other recalls since October 9, 2019. Other recent recalls include the Nextra Hammertoe Correction System (February 10, 2022) and the Nextrem Cannulated Hammertoe Kit (January 13, 2022). Similar products have faced issues such as the Medline DEXLOCK Achilles Repair Kits drill bit fusing risk (November 11, 2025), Orthalign Drill Plate bone cut risk (February 10, 2026), and Surgify Halo 5.4mm drill burr breakage (April 30, 2026).
How to tell if you have this one
Check for the part number IC-LAP-28L on the kit. The product is used for internal fixation in foot surgery (First Metatarsocuneiform arthrodesis).
Brand
Nextremity Solutions
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
AL, AK, CA, IA,IL, IN, KY ,MD. MI, NJ, NY, OR, PA, SC, TX, VA
Recall number
Product, codes & lots
Quantity
Z-1500-2021
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.; Lot Number: 168B29619A UDI: 00817701020868
111 units
Z-1501-2021
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.; Lot Number: 168B29619B UDI: 00817701020875
123 units
Based on the official FDA remedy
What to do — step by step
Contact Manufacturer
Reach out to Nextremity Solutions for specific instructions on how to get the kit replaced or corrected.
Where it went and when
Where it was distributed
Distributed in 16 states.
Listed by the agency
Not listed
FDA distribution: “AL, AK, CA, IA,IL, IN, KY ,MD. MI, NJ, NY, OR, PA, SC, TX, VA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Alaska, California, Illinois, Indiana, Iowa, Kentucky, Maryland, Michigan, New Jersey, New York, Oregon, Pennsylvania, South Carolina, Texas, Virginia.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1500-2021 (March 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1500-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.