Recall Z-0740-2022— Nextremity Solutions
Class II · Terminated
Class II FDA medical device recall by Nextremity Solutions, initiated 2022-01-13, terminated 2024-05-24. It names 2 FDA 510(k) clearances: K213530, K200840. Product: Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toe SKU: CH-STD-KT. 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.
- Recalling firm
- Nextremity Solutions
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-01-13
- Terminated
- 2024-05-24
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toe SKU: CH-STD-KT
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.