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
Check against the official notice below — it lists the full affected range.
Nextremity Solutions has recalled 24 units of the Nextra Cannulated Hammertoe Standard Instrument Kit, which is used for small bone reconstruction in toe repair and fusion procedures. The recall affects specific lot numbers (1574701 and 158961) distributed nationwide across Arizona, Illinois, Georgia, Louisiana, Maryland, New York, Pennsylvania, Texas, and Washington. The problem involves the driver tool potentially deforming the implant locking mechanism during middle phalanx implant insertion, which can prevent proper connection between implants and lead to surgical complications including delays, implant removal during surgery, need for alternative surgical approaches, and revision procedures.
The recall source does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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. Quantity: 24 units Lot/code info: Lot Numbers: 1574701, 158961 UDI: 00817701026372
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.