Home / Recalls / Nextremity Solutions / Z-0739-2022

Z-0739-2022 Class II Terminated

Recalled by Nextremity Solutions — Warsaw, IN

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
23 units

Product 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

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 Number: 1578401 UDI: 00817701026389

Other recalls by Nextremity Solutions

  • Z-0914-2022 Class II — Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical ins (February 10, 2022)
  • Z-0912-2022 Class II — Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K (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-0910-2022 Class II — Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K (February 10, 2022)
  • Z-0740-2022 Class II — Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone rec (January 13, 2022)
  • Z-1501-2021 Class II — InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usag (March 26, 2021)
  • Z-1500-2021 Class II — InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage (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)