| Class 3 Device Recall Radiesse Injectable Implant | |
Date Initiated by Firm | April 06, 2011 |
Date Posted | 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
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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 WI 53126-9127
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For Additional Information Contact | 262-286-4025 |
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 |
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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.
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PMA Database | PMAs with Product Code = LMH
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