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Terminated

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.

FDA Recall Z-2607-2016 · Posted 2016-08-19

Recalling FirmMerz North America, Inc.
Recall StatusTerminated
Product CodeLMH
Date Initiated2016-05-20
Date Terminated2017-05-08
Product Quantity1,591 units

Reason for Recall

Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.

Firm Action

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 [email protected]. For questions contact Merz at (262) 835-3300 ext. 2627.

Root Cause

Nonconforming Material/Component

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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