Home / Recalls / Zimmer Biomet Spine, Inc / Z-2398-2016

Z-2398-2016 Class II Terminated

Recalled by Zimmer Biomet Spine, Inc — Broomfield, CO

Recall Details

Product Type
Devices
Report Date
August 17, 2016
Initiation Date
June 30, 2016
Termination Date
March 15, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5

Product Description

Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.

Reason for Recall

Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston¿ Transform Instrument Case and Zyston¿ Transform Implant Kit because the locking mechanism on the implant is not functioning as intended.

Distribution Pattern

Nationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees.

Code Information

Lot Numbers: 2016244391; 2016244394; 2016244395; 2016244396; 2016244397; 2016244424; 2016244426; 2016244427; 2016244428; 2016244430.

Other recalls by Zimmer Biomet Spine, Inc

  • Z-0639-2024 Class II — Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and (October 16, 2023)
  • Z-0867-2019 Class II — Vitality¿ Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (non (July 30, 2018)
  • Z-0866-2019 Class II — Vitality¿ Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-s (July 30, 2018)
  • Z-0868-2019 Class II — Vitality¿ Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation (July 30, 2018)
  • Z-2318-2017 Class II — Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque (May 10, 2017)
  • Z-1691-2017 Class II — Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The A (March 16, 2017)
  • Z-2397-2016 Class II — Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled ste (June 30, 2016)