Recall Z-2607-2016 ยท LMH Implant, Dermal, For Aesthetic Use
Merz North America, Inc.
Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE is indicated for sub-dermal implantation for the correction of moderate to severe facial wrinkles and folds.
| Date | Aug 19, 2016 (initiated May 20, 2016) |
| Status | Terminated |
| Reason | Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle. |
| Root cause | Nonconforming Material/Component |
| Action | Merz sent an Urgent Medical Device Recall Letter dated May 20, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to complete the enclosed response form and return via fax to (262) 835-3330 or email to complaints2@merz.com. For questions contact Merz at (262) 835-3300 ext. 2627. |
| Quantity | 1,591 units |
| Distribution | US Nationwide Distribution in the states of AR, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.