Z-2221-2011

Radiesse, Injectable Implant - 1.3cc Syringe, Sterile, Sterilized Using Steam, Use Before 2013-01, Ref...

Name: Z-2221-2011 Radiesse, Injectable Implant - 1.3cc Syringe, Sterile, Sterilized Using Steam, Use Before 2013-01, Ref...
Creator: Merz Aesthetics, Inc.
Published: 2011-04-06
License: https://open.fda.gov/license/

Merz North America, Inc. / initiated 2011-04-06 / Terminated / root cause: manufacturing process

FDA source

Merz Aesthetics, Inc. began a recall of Radiesse, Injectable Implant - 1.3cc Syringe, Sterile, Sterilized Using Steam, Use Before 2013-01, Ref 8046M7, Lot 1024417, Manufactured by: BioForm Medical... on 2011-04-06. The reason FDA records is "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 of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2221-2011
Status: Terminated
Initiated: 2011-04-06
Posted: 2011-05-19
Terminated: 2011-11-17
Recalling firm: Merz North America, Inc.
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.
Product code: LMH Implant, Dermal, For Aesthetic Use
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Lot 1024417

Product code LMH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)