Z-0366-2016 Class II Terminated
FDA device recall Z-0366-2016 was initiated by Merz North America, Inc. on October 26, 2015 and is designated Class II. Reason for recall: The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect. The recall status is terminated (terminated May 8, 2017). Affected quantity: 1,616 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 9, 2015
- Initiation Date
- October 26, 2015
- Termination Date
- May 8, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,616 units
Product Description
Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.
Reason for Recall
The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
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.
Code Information
Lot No. 100083189