Home / Recalls / Nextremity Solutions / Z-1500-2021

Z-1500-2021 Class II Terminated

Recalled by Nextremity Solutions — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
May 5, 2021
Initiation Date
March 26, 2021
Termination Date
November 10, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
111 units

Product Description

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

Distribution Pattern

AL, AK, CA, IA,IL, IN, KY ,MD. MI, NJ, NY, OR, PA, SC, TX, VA

Code Information

Lot Number: 168B29619A UDI: 00817701020868

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  • Z-1501-2021 Class II — InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usag (March 26, 2021)
  • Z-1458-2020 Class II — Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. R (February 12, 2020)
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