Recall Z-1500-2021— Nextremity Solutions
Class II · Terminated
Class II FDA medical device recall by Nextremity Solutions, initiated 2021-03-26, terminated 2021-11-10. FDA's recall record names no specific 510(k) clearance for this event. 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.
- Recalling firm
- Nextremity Solutions
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-03-26
- Terminated
- 2021-11-10
- Firm location
- Warsaw, IN, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.