Device product
Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.
Z-0366-2016
Product summary
- Event
- Event 72585
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,616 units
- Official record key
device-enforcement:Z-0366-2016
Official wording
Reason: The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
Code information: Lot No. 100083189
Distribution pattern: 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.
Derived failure modes
-
Labeling or packaging
label is incorrect