FDA Device recall 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…
- FDA Device
- Class II
- terminated
- Published 2021-05-05
On 2021-05-05 the FDA classified a Class II recall of InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct intended for internal… by Nextremity Solutions, citing 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 inab….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1500-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-26 |
| Published | 2021-05-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Nextremity Solutions |
| Distribution | AK, AL, CA, IA, IL, IN, KY, MD, MI, NJ, NY, OR, PA, SC, TX, VA |
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
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
Identifiers
| code_info | Lot Number: 168B29619A UDI: 00817701020868 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1500-2021%22
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