The Recall Desk
HighFDA (Devices)·Z-0739-2022·Announced 2022-03-16

Nextra CH Hammertoe Surgical Implant Kit Recalled for Locking Mechanism Defect

Nextremity Solutions recalls the Nextra CH Hammertoe Mini Instrument Kit for a defect that may deform the implant's locking mechanism during insertion, potentially requiring revision surgery.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of an orthopedic surgical implant with a mechanical defect that could result in surgical complications. The defect poses a clear risk of harm during surgical procedures, meeting the criterion for high-severity risk-of-harm products where injury has not yet been reported.

Plain-English summary

The Nextra CH Cannulated Hammertoe Mini Instrument Kit, manufactured by Nextremity Solutions, is being recalled due to a mechanical defect affecting the implant's locking mechanism. During insertion of the middle phalanx implant, the surgical driver may deform the locking mechanism, resulting in inadequate mating force between the middle and proximal phalanx implants.

This defect could lead to surgical complications including surgical delays, in-situ implant removal, the need to use an alternative surgical approach, post-operative disassembly of the implants, and revision surgery. The recall affects 23 units distributed nationwide in Arizona, Illinois, Georgia, Louisiana, Maryland, New York, Pennsylvania, Texas, and Washington.

Healthcare providers and patients who have received this implant should consult with their orthopedic surgeon to determine if their specific implant is affected. Surgeons should review the lot number (1578401) and UDI (00817701026389) to identify recalled devices.

The recalled product

Product
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
Manufacturer
Nextremity Solutions
Category
Medical Device — Orthopedic Surgical Implant
Hazard
  • mechanical-defect
  • surgical-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number: 1578401 UDI: 00817701026389

Distribution

Distributed nationwide across the United States.

Related recalls

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