Recall Z-2221-2011 ยท LMH Implant, Dermal, For Aesthetic Use
Merz Aesthetics, Inc.
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 fac
| Date | May 19, 2011 (initiated Apr 6, 2011) |
| Status | Terminated |
| Reason | 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 | 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 | 695 units |
| Distribution | International only: Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.