Nextremity Solutions: Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes SKU: CH-MINI-KT

Is my product affected?

Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes SKU: CH-MINI-KT

• UPC 00817701026389

Check against the official notice below — it lists the full affected range.

What happened

Nextremity Solutions has recalled the Nextra CH Cannulated Hammertoe Mini Instrument Kit, a surgical instrument used for small bone reconstruction and repair of the lesser toes. The recall affects 23 units distributed nationwide across Arizona, Illinois, Georgia, Louisiana, Maryland, New York, Pennsylvania, Texas, and Washington. The issue involves Lot Number 1578401 (UDI: 00817701026389).

The problem occurs when the driver used to insert the middle phalanx implant into bone may deform the implant's locking mechanism, preventing adequate mating force between the middle and proximal phalanx implants. This defect can cause surgical delays, require removal of the implant during the procedure, necessitate use of an alternative surgical approach, require disassembly of implants after surgery, or result in the need for revision surgery. The source document does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

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

Details from the source

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: 23 units Lot/code info: Lot Number: 1578401 UDI: 00817701026389

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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