FDA recall Z-0740-2022

Nextremity Solutions · Class II · device

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 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

Distribution

US Nationwide distribution in the states of AZ, IL, GA, LA, MD, NY, PA, TX, WA.

Key facts

Status
Terminated
Initiation date
2022-01-13
Report date
2022-03-16
Termination date
2024-05-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0740-2022