Meddev Corp: Device Recall

Recall #Z-1745-2025 · 07/12/2024

Class II: Risk

Recall Details

Recall Number
Z-1745-2025
Classification
Class II
Product Type
Device
Recalling Firm
Meddev Corp
Status
Ongoing
Date Initiated
07/12/2024
Location
Sunnyvale, CA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
34 weights

Reason for Recall

Due to mislabeling of products

Product Description

Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3012 Product Description: Contour Gold Eyelid Weight, 1.2 gm MedDev Contour and ThinProfile Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted permanent lagophthalmos, usually resulting from facial paralysis.

Distribution Pattern

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.

Other Recalls by Meddev Corp

View all recalls by Meddev Corp →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.