Recall Z-0366-2016— Merz North America, Inc.
Class II · Terminated
Class II FDA medical device recall by Merz North America, Inc., initiated 2015-10-26, terminated 2017-05-08. Product: Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.. Reason: The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect..
- Recalling firm
- Merz North America, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-10-26
- Terminated
- 2017-05-08
- Firm location
- Raleigh, NC, United States
Product description
Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.