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Recall Observatory FDA recall evidence

Device product

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

Z-2398-2016

June 30, 2016

Class II

Product summary

Firm
Zimmer Biomet Spine, Inc
Event
Event 74687
Status
Terminated
Classification
Class II
Quantity
5
Official record key
device-enforcement:Z-2398-2016

Official wording

Reason: 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.

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.