Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE is in
FDA device recall Z-2607-2016 · posted 2016-08-19 · Terminated
Recall details
- Recalling firm
- Merz North America, Inc.
- Reason for recall
- Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LMH
- Quantity affected
- 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.
- Date initiated
- 2016-05-20
- Date posted
- 2016-08-19
- Date terminated
- 2017-05-08
- Location
- Raleigh, NC
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