medical Class II Updated 2022-03-16

Nextremity Solutions recalls Nextra Cannulated Hammertoe Standard Instrument Kit-indicate

Recalled 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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: 1574701, 158961 UDI: 00817701026372
View official government recall

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