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Nextremity Solutions Recall 89588

Description: 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

Nextremity Solutions Recall 89588 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0739-2022
Event ID89588
Event DescriptionNextra 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
Product TypeDevices
DistributionUS Nationwide distribution in the states of AZ, IL, GA, LA, MD, NY, PA, TX, WA.
Quantity23 units
Recall ReasonDuring 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
Device Classification20220316
Device Code InfoLot Number: 1578401 UDI: 00817701026389
Center Classification Date20220309
Recall Initiation Date20220113
Recalling FirmNextremity Solutions
Initial Notification Letter
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