Z-0740-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 16, 2022
- Initiation Date
- January 13, 2022
- Termination Date
- May 24, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 units
Product Description
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
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 Pattern
US Nationwide distribution in the states of AZ, IL, GA, LA, MD, NY, PA, TX, WA.
Code Information
Lot Numbers: 1574701, 158961 UDI: 00817701026372