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Terminated

Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.

FDA Recall Z-0366-2016 · Posted 2015-12-03

Recalling FirmMerz North America, Inc.
Recall StatusTerminated
Product CodeLMH
Date Initiated2015-10-26
Date Terminated2017-05-08
Product Quantity1,616 units

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.

Firm Action

Letters dated 11/4/2015 were sent to customers with tracking and delivery confirmation. The letter informs the customer that they may continue to safely use the affected product by referring to the USE BEFORE date.

Root Cause

Other

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.

Official Source

View FDA Recall →

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

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