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Nextremity Solutions recalls Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital rep
Recalled March 16, 2022 · FDA recall Z-0740-2022 · Nextremity Solutions
Hazard
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 · FDA Class II
Units
24 units
Sold at
US Nationwide distribution in the states of AZ, IL, GA, LA, MD, NY, PA, TX, WA.
Description
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
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
Manufacturer(s)
Nextremity Solutions
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →