Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3012 Product Description: Contour G
FDA device recall Z-1745-2025 · posted 2025-05-09 · Open, Classified
Recall details
- Recalling firm
- Meddev Corp
- Reason for recall
- Due to mislabeling of products
- Action taken
- 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)
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- NCB
- Quantity affected
- 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.
- Date initiated
- 2024-07-12
- Date posted
- 2025-05-09
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants (K150986) | Meddev Corporation | 2015-08-17 |