FDA-Device2015-12-09Class II
PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Model No. 8044M0K5. An injectable implant used to treat vocal fold insufficiency.
Merz North America, Inc.
Hazard
The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
Sold states
Distributed US (nationwide) including the Virgin Islands and South Africa.
Affected count
9,439 units
Manufactured in
6501 Six Forks Rd, Raleigh, NC, United States
Products
PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Model No. 8044M0K5. An injectable implant used to treat vocal fold insufficiency.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0368-2016Don't want to check this manually?
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