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Recall Observatory FDA recall evidence

Device product

Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.

Z-2744-2015

August 05, 2015

Class II

Product summary

Firm
Biomet Spine, LLC
Event
Event 71940
Status
Terminated
Classification
Class II
Quantity
7 parts
Official record key
device-enforcement:Z-2744-2015

Official wording

Reason: Some of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440.

Code information: Model Number 14-521614B, lot number 375440.

Distribution pattern: Nationwide Distribution including Distributed nationwide to OH, LA, TX, and GA.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled