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U.S. Department of Health and Human Services

Class 2 Device Recall Radiesse

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  Class 2 Device Recall Radiesse see related information
Date Initiated by Firm May 20, 2016
Date Posted August 19, 2016
Recall Status1 Terminated 3 on May 08, 2017
Recall Number Z-2607-2016
Recall Event ID 74252
PMA Number P050052 
Product Classification Implant, Dermal, For Aesthetic Use - Product Code LMH
Product Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics.

Product Usage:
RADIESSE is indicated for sub-dermal implantation for the correction of moderate to severe facial wrinkles and folds.
Code Information Model number: 8063M0K1, Lot #100088744.
Recalling Firm/
Manufacturer		 Merz North America, Inc.
6501 Six Forks Rd
Raleigh NC 27615-6515
Manufacturer Reason
for Recall		 Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Merz sent an Urgent Medical Device Recall Letter dated May 20, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to complete the enclosed response form and return via fax to (262) 835-3330 or email to complaints2@merz.com. For questions contact Merz at (262) 835-3300 ext. 2627.
Quantity in Commerce 1,591 units
Distribution US Nationwide Distribution in the states of AR, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT and WA.
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
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