Recall Z-1501-2021 ยท HWC Screw, Fixation, Bone
Nextremity Solutions
InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.
| Date | Mar 26, 2021 |
| Status | Terminated |
| 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 |
| Root cause | Under Investigation by firm |
| Action | Nextremity Solutions issued Urgent Medical Device Recall Letter to Distributors and Risk Managers on March 26,2021 stating reason for recall, health risk and action to take: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 - Medical Device Recall Return Response and send to Corporate Quality.PostMarket@zi |
| Quantity | 123 units |
| Distribution | AL, AK, CA, IA,IL, IN, KY ,MD. MI, NJ, NY, OR, PA, SC, TX, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.