Medical device recalls Moderate risk

Meddev product recalled over labeling errors

Recall date
July 12, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Meddev Corp recalls Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3010 Product Description: Contour…
Recall number
Z-1744-2025
FDA classification
Class II
Brand / firm
Meddev Corp
Sold / distributed
U.S. Nationwide distribution in the states of CA, CO, CT, FL, IA, IL, MA, ME, MI, NE, NY, OH, OK, OR, SC, TX, and WV.

Why it was recalled

Due to mislabeling of products

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

What was recalled

Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3010 Product Description: Contour Gold Eyelid Weight, 1.0 gm MedDev Contour and ThinProfile Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted permanent lagophthalmos, usually resulting from facial paralysis.

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