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Merz North America, Inc. recalls PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Model No. 8044M0K5. An
Recalled December 9, 2015 · FDA recall Z-0368-2016 · 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
9,439 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 PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Model No. 8044M0K5. An injectable implant used to treat vocal fold insufficiency.
Manufacturer(s)
Merz North America, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →