Home / Recalls / Nextremity Solutions / Z-0912-2022

Z-0912-2022 Class II Terminated

Recalled by Nextremity Solutions — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
April 20, 2022
Initiation Date
February 10, 2022
Termination Date
October 10, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
285 units

Product Description

Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgical instrument

Reason for Recall

Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery

Distribution Pattern

Distribution US Nationwide, Japan, and the Netherlands

Code Information

Lot Number: 168125017A UDI: 00817701020042

Other recalls by Nextremity Solutions

  • Z-0910-2022 Class II — Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K (February 10, 2022)
  • Z-0914-2022 Class II — Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical ins (February 10, 2022)
  • Z-0913-2022 Class II — Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX (February 10, 2022)
  • Z-0911-2022 Class II — Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: N (February 10, 2022)
  • Z-0739-2022 Class II — Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reco (January 13, 2022)
  • Z-0740-2022 Class II — Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone rec (January 13, 2022)
  • Z-1500-2021 Class II — InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage (March 26, 2021)
  • Z-1501-2021 Class II — InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usag (March 26, 2021)
  • Z-1458-2020 Class II — Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. R (February 12, 2020)
  • Z-1127-2020 Class II — Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The (December 16, 2019)