Class 2 Device Recall Radiesse () Injectable Implant

• Date Initiated by Firm: October 26, 2015
• Date Posted: December 03, 2015
• Recall Status: Terminated on May 08, 2017
• Recall Number: Z-0366-2016
• Recall Event ID: 72585
• PMA Number: P050052/SO52
• Product Classification: Implant, dermal, for aesthetic use - Product Code LMH
• Product: Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.
• Code Information: Lot No. 100083189
• Recalling Firm/ Manufacturer: Merz North America, Inc.; 6501 Six Forks Rd; Raleigh NC 27615-6515
• For Additional Information Contact: 866-862-8211
• Manufacturer Reason for Recall: The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
• FDA Determined Cause: Other
• Action: Letters dated 11/4/2015 were sent to customers with tracking and delivery confirmation. The letter informs the customer that they may continue to safely use the affected product by referring to the USE BEFORE date.
• Quantity in Commerce: 1,616 units
• Distribution: Nationwide Distribution including the states of AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, LA, MD, MA, MI, MN, MO, NV, NH, NJ, NY, NC, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WI.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = LMH and Original Applicant = MERZ NORTH AMERICA, INC