Recall Z-0366-2016 ยท LMH Implant, Dermal, For Aesthetic Use
Merz North America, Inc.
Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.
| Date | Dec 3, 2015 (initiated Oct 26, 2015) |
| Status | Terminated |
| Reason | The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect. |
| Root cause | Other |
| Action | Letters dated 11/4/2015 were sent to customers with tracking and delivery confirmation. The letter informs the customer that they may continue to safely use the affected product by referring to the USE BEFORE date. |
| Quantity | 1,616 units |
| Distribution | Nationwide Distribution including the states of AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, LA, MD, MA, MI, MN, MO, NV, NH, NJ, NY, NC, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.