Radiesse, Injectable Implant - 1.3cc Syringe, Sterile… recallZ-2221-2011 · Merz Aesthetics, Inc. · initiated Apr 6, 2011
Terminated All recalls posted in May 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Merz Aesthetics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Employee error
What the company is doing
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.
Recall details
- Recall number
- Z-2221-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 6, 2011
- Posted by the FDA
- May 19, 2011
- Recalling firm
- Merz Aesthetics, Inc.
- Quantity
- 695 units
- Product code
- LMH
- FDA submissions
- P050052, P050037
- Distribution
- International only: Taiwan.
Product description
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 (models, lots, serial numbers)
Lot 1024417
Other devices under the same FDA submission
5 devices cleared under P050052, P050037 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Radiesse (+) Lidocaine 8063M0K2Merz North America, Inc. · Implant, Dermal, For Aesthetic Use61 reports
- Radiesse Volume Advantage 8071M0K2Merz North America, Inc. · Implant, Dermal, For Aesthetic Use26 reports
- Radiesse (+) Lidocaine1.5cc Injectable Implant 8063M0K1Merz North America, Inc. · Implant, Dermal, For Aesthetic Use12 reports
- Radiesse Volume Advantage 1.5cc 8071M0K1Merz North America, Inc. · Implant, Dermal, For Aesthetic Use8 reports
- Radiesse Injectable Implant1.5cc 8071M0H1Merz North America, Inc. · Implant, Dermal, For Aesthetic Use1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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