Z-1500-2021 Class II Terminated
FDA device recall Z-1500-2021 was initiated by Nextremity Solutions on March 26, 2021 and is designated Class II. 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 c… The recall status is terminated (terminated November 10, 2021). Affected quantity: 111 units.
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