Class 2 Device Recall Contour

• Date Initiated by Firm: July 12, 2024
• Date Posted: May 09, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1745-2025
• Recall Event ID: 96551
• 510(K)Number: K150986
• Product Classification: Weights, eyelid, implantable - Product Code NCB
• Product: 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.
• Code Information: Model No LL3012; UDI code: 010081314202039917260727107228 Lot Number: 7228
• FEI Number: 2921577
• Recalling Firm/ Manufacturer: Meddev Corp; 730 N Pastoria Ave; Sunnyvale CA 94085-3522
• For Additional Information Contact: Catherine Leong; +1-408-7309702
• Manufacturer Reason for Recall: Due to mislabeling of products
• FDA Determined Cause: Process control
• Action: On 07/12/2024, the firm sent a customer notification letter via first class mail to inform customers that the labels on the Contour Gold Eyelid Implants LL3010/Lot # 7227 potentially do not match the weight; the implants labeled LL3010 (1.0 gm) may contain LL3012 (1.2 gm). Customers are instructed to check their inventory for any/all of the affected products and to contact MedDev Corporation to request for an RGA number in or return affected products and receive replacement products. For questions/concerns contact Quality Compliance Specialist at 1-800-543-2789 or email catherine@meddev-corp.com An updated "URGENT: MEDICAL DEVICE RECALL" Letter was distributed to customers on 04/17/2025. Updated Customer Letter is informing customer that the potential product mix-up may include an additional product and lot number (Model Number LL3012 and Lot Number 7228)
• Quantity in Commerce: 34 weights
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NCB