Reported Aug 31, 2016 · Terminated
Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE is…
Merz North America, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merz North America, Inc. · 6501 Six Forks Rd · Raleigh, NC · 27615-6515
Is this the product you have?
- Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only
- P/N8063M0K1, Merz Aesthetics
- Product UsageRADIESSE is indicated for sub-dermal implantation for the correction of moderate to severe facial wrinkles and folds
- Lot codes and dates
- Model number
8063M0K1Lot #100088744
- Model number
- Amount recalled
- 1,591 units
Where it was sold
Why it was recalled
Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
This product could cause temporary or reversible health problems — stop using it.
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