Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 fixation for First Metatarsocuneiform arthrodesis.

U.S. FDA — Device Enforcement · United States · 2021-03-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1500-2021
Date of alert
2021-03-26
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Nextremity Solutions
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00817701020868
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.