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U.S. Department of Health and Human Services

Class 3 Device Recall Radiesse Injectable Implant

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  Class 3 Device Recall Radiesse Injectable Implant see related information
Date Initiated by Firm April 06, 2011
Date Posting Updated May 19, 2011
Recall Status1 Terminated 3 on November 17, 2011
Recall Number Z-2221-2011
Recall Event ID 58614
PMA Number P050052 P050037 
Product Classification Implant, dermal, for aesthetic use - Product Code LMH
Product Radiesse, Injectable Implant - 1.3cc Syringe, Sterile, Sterilized Using Steam, Use Before 2013-01, Ref 8046M7, Lot 1024417, Manufactured by: BioForm Medical Inc, 4133 Courtney Rd #10 Franksville, WI 53126.

Subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as masolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.
Code Information Lot 1024417
Recalling Firm/
Merz Aesthetics, Inc.
4133 Courtney Rd
Suite 10
Franksville WI 53126-9127
For Additional Information Contact
Manufacturer Reason
for Recall
Merz Aesthetics, Inc. is recalling 1 lot (1034417) of Radiesse 1.3 cc Implant. The lot was supposed to be scrapped because it had failed to meet its Loss On Drying (LOD) specification. Unfortunately it had been marked as approved, released and shipped.
FDA Determined
Cause 2
Employee error
Action The firm, Merz Aesthetics, Inc., contacted its consignee/customer via e-mail on April 6, 2011. The e-mail states the product, problem and action to be taken. The customer was instructed to follow up with the concerned and inform the status time to time to the Recall Coordinator. The product was confirmed to be quarantined and has been requested to be sent back. If you need any additional information regarding this issue or if you have any questions, contact the International Regulatory Affairs Specialist at 262-835-3300 ext. 3081.
Quantity in Commerce 695 units
Distribution International only: Taiwan.
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