Nextremity Solutions Recall 89588
Description: Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes SKU: CH-MINI-KT
Nextremity Solutions Recall 89588 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0739-2022 |
| Event ID | 89588 |
| Event Description | Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes SKU: CH-MINI-KT |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of AZ, IL, GA, LA, MD, NY, PA, TX, WA. |
| Quantity | 23 units |
| Recall Reason | During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in surgical delay, in-situ removal of the implant, use of alternative surgical approach, disassembly of the implants post-operatively, and revision |
| Device Classification | 20220316 |
| Device Code Info | Lot Number: 1578401 UDI: 00817701026389 |
| Center Classification Date | 20220309 |
| Recall Initiation Date | 20220113 |
| Recalling Firm | Nextremity Solutions |
| Initial Notification | Letter |
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