FDA-Device2015-12-09Class II
PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation.
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
7,715 units
Manufactured in
6501 Six Forks Rd, Raleigh, NC, United States
Products
PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0367-2016Don't want to check this manually?
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