Nextremity Solutions Recall 87665
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.
Nextremity Solutions Recall 87665 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1500-2021 |
| Event ID | 87665 |
| Event 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. |
| Product Type | Devices |
| Distribution | AL, AK, CA, IA,IL, IN, KY ,MD. MI, NJ, NY, OR, PA, SC, TX, VA |
| Quantity | 111 units |
| Recall 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 |
| Device Classification | 20210505 |
| Device Code Info | Lot Number: 168B29619A UDI: 00817701020868 |
| Center Classification Date | 20210427 |
| Recall Initiation Date | 20210326 |
| Recalling Firm | Nextremity Solutions |
| Initial Notification | |
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