Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction
FDA device recall Z-0366-2016 · posted 2015-12-03 · Terminated
Recall details
- Recalling firm
- Merz North America, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- LMH
- Quantity affected
- 1,616 units
- Distribution
- 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.
- Date initiated
- 2015-10-26
- Date posted
- 2015-12-03
- Date terminated
- 2017-05-08
- Location
- Raleigh, NC
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