Medical device recalls Moderate risk

Biomet Parsippany recalled over labeling errors

Recall date
August 5, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Biomet Spine, LLC recalls Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.
Recall number
Z-2744-2015
FDA classification
Class II
Brand / firm
Biomet Spine, LLC
Sold / distributed
Nationwide Distribution including Distributed nationwide to OH, LA, TX, and GA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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