Z-2607-2016 Class II Terminated
FDA device recall Z-2607-2016 was initiated by Merz North America, Inc. on May 20, 2016 and is designated Class II. Reason for recall: Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle. The recall status is terminated (terminated May 8, 2017). Affected quantity: 1,591 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 31, 2016
- Initiation Date
- May 20, 2016
- Termination Date
- May 8, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,591 units
Product Description
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.
Reason for Recall
Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
Distribution Pattern
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.
Code Information
Model number: 8063M0K1, Lot #100088744.