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U.S. Department of Health and Human Services

Class 2 Device Recall Radiesse () Injectable Implant

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 Class 2 Device Recall Radiesse () Injectable Implantsee related information
Date Initiated by FirmOctober 26, 2015
Date PostedDecember 03, 2015
Recall Status1 Terminated 3 on May 08, 2017
Recall NumberZ-0366-2016
Recall Event ID 72585
PMA NumberP050052/SO52 
Product Classification Implant, dermal, for aesthetic use - Product Code LMH
ProductRadiesse (+) 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 2		Other
ActionLetters 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 Commerce1,616 units
DistributionNationwide 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 CycleTPLC 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 DatabasePMAs with Product Code = LMH
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