Z-1745-2025 Class II Ongoing
FDA device recall Z-1745-2025 was initiated by Meddev Corp on July 12, 2024 and is designated Class II. Reason for recall: Due to mislabeling of products The recall status is ongoing. Affected quantity: 34 weights.
Recall Details
- Product Type
- Devices
- Report Date
- May 21, 2025
- Initiation Date
- July 12, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34 weights
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.
Reason for Recall
Due to mislabeling of products
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.
Code Information
Model No LL3012; UDI code: 010081314202039917260727107228 Lot Number: 7228