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Recall Observatory FDA recall evidence

Device product

Zeus-P Lumbar Interbody Device

Z-0827-2017

November 22, 2016

Class II

Product summary

Firm
Amendia, Inc
Event
Event 75855
Status
Terminated
Classification
Class II
Quantity
25 units
Official record key
device-enforcement:Z-0827-2017

Official wording

Reason: Labeling error where three boxes in inventory had conflicting patient and primary labels. Evaluation indicated that the primary label and patient label did not match. The primary label matched the label on the inner pouch, but the patient label was incorrect.

Code information: Part Number 1-110926B - Lot Number 128945 and Part Number 1-120922B - Lot Number 128946

Distribution pattern: US Distribution to the states of : GA. MI, OK, SC, TX, VA

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling error