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Merz North America, Inc. recalls PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstruct
Recalled December 9, 2015 · FDA recall Z-0367-2016 · Merz North America
Hazard
The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect. · FDA Class II
Units
7,715 units
Sold at
Distributed US (nationwide) including the Virgin Islands and South Africa.
Description
The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
Product
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.
Manufacturer(s)
Merz North America, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →