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Recall Observatory FDA recall evidence

Device 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

Z-0739-2022

January 13, 2022

Class II

Product summary

Firm
Nextremity Solutions
Event
Event 89588
Status
Terminated
Classification
Class II
Quantity
23 units
Official record key
device-enforcement:Z-0739-2022

Official wording

Reason: 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

Code information: Lot Number: 1578401 UDI: 00817701026389

Distribution pattern: US Nationwide distribution in the states of AZ, IL, GA, LA, MD, NY, PA, TX, WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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