FDA Device recall Z-0367-2016

PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occ…

FDA Device
Class II
terminated
Published 2015-12-09

On 2015-12-09 the FDA classified a Class II recall of PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occ… by Merz North America, citing the expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0367-2016
Classification	Class II
Status	terminated
Initiated	2015-10-26
Published	2015-12-09
Last updated	2026-09-13 11:53 UTC
Company	Merz North America
Distribution	US

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.

Reason

The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.

Identifiers

code_info	Lot Number 100079214, 100077099, 100077251, 100077252, 100077253, 100078692, 100079598, 100080204, 100081409, 10008157… Lot Number 100079214, 100077099, 100077251, 100077252, 100077253, 100078692, 100079598, 100080204, 100081409, 100081577, 100082304, 100082438, 100083371, 100083875, 100083932

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0367-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.