FDA Medical Device Recalls (openFDA)
Merz North America, Inc.: Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.
- Recall number
- Z-0366-2016
- Recalling firm
- Merz North America, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2015-10-26
- Posted
- 2015-12-03
- Terminated
- 2017-05-08
- Reason
- The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
- Root cause
- Other
- 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.
- Quantity
- 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.
- Lot, serial or model codes
- Lot No. 100083189
- 510(k) numbers
- not on file
- PMA numbers
- ["P050052/SO52"]
- Product code
- LMH
- Firm FEI
- 1012187
- Firm city
- Raleigh
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28