Recall Z-0145-2012 ยท LMH Implant, Dermal, For Aesthetic Use
Merz Aesthetics, Inc.
MERZ AESTHETICS, Radiesse Volume Advantage 1.5 CC, Injectable Implant, Part Number 8071M0H1 and 8071M0K1, Sterile, Rx ONLY. Part Number 8071M4K1 distributed in Canada Part Number 8071M5 distributed in Europe/Middle East/Africa Part Number 8071M9 distributed in Hong Kong, Korea, Malaysia.
| Date | Nov 1, 2011 (initiated Aug 18, 2011) |
| Status | Terminated |
| Reason | There is a potential leakage of product that may occur with Merz Aesthetics 1.5cc syringes of Radiesse Dermal Filler. When using the syringe, Health Care Professionals should be alerted to the potential for product that my leak pass the plunger at the proximal end of the syring. The defect may result in infection requiring medical intervention to prevent impairment or damage. To date Merz has n |
| Root cause | Nonconforming Material/Component |
| Action | On 8/18/11, consignees were sent a Merz Aesthetics "Urgent Medical Device Recall" letter dated August 15, 2011. The letter was addressed to "Dear Health Care Professional". The letter described the product and the problem and listed the details regarding this issue. |
| Quantity | 311,582 |
| Distribution | Worldwide distribution including USA, Puerto Rico, Dominican Republic, Hong Kong, Israel, Netherlands, Germany, South Korea, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.