InCore Lapidus Disposable Kit 28mm Left — Class II medical device recall Z-1500-2021
Terminated recall by Nextremity Solutions, reported 2021-05-05, distributed in AK, AL, CA, IA, IL, IN, KY, MD…. Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not a
| Recall number | Z-1500-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nextremity Solutions, Warsaw, IN, United States |
| Recall initiated | 2021-03-26 |
| Classified | 2021-04-27 |
| Reported by FDA | 2021-05-05 |
| Terminated | 2021-11-10 |
| Distributed | AK, AL, CA, IA, IL, IN, KY, MD, MI, NJ, NY, OR, PA, SC, TX, VA |
| Quantity | 111 units |
| UPC / GTIN / UDI-DI | 00817701020868 |
| Lot numbers | 168B29619A |
| Model numbers | IC-LAP-28L |
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.
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1500-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.