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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 Recall
Radiesse Injectable Implant
see related information
Date Posted May 19, 2011
Recall Status1 Terminated on November 17, 2011
Recall Number Z-2221-2011
Recall Event ID 58614
Premarket Approval
PMA Numbers
P050037 P050052
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/
Manufacturer
Merz Aesthetics, Inc.
4133 Courtney Rd
Suite 10
Franksville, Wisconsin 53126-9127
Consumer Instructions Contact the recalling firm for information
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
TRAINING: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LMH and Applicant = BIOFORM MEDICAL, INC.
PMAs with Product Code = LMH and Applicant = MERZ AESTHETICS, INC.
PMAs with Product Code = LMH and Applicant = MERZ NORTH AMERICA, INC
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