Z-0367-2016Class II

PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical...

Name: Z-0367-2016 PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical...
Creator: Merz North America, Inc.
Published: 2015-10-26
License: https://open.fda.gov/license/

Merz North America, Inc. / initiated 2015-10-26 / Terminated / root cause: labeling and UDI

FDA source

Merz North America, Inc. began a recall of 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... on 2015-10-26. FDA classified it as Class II and gives the reason as "The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0367-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-26
Posted: 2015-12-03
Terminated: 2017-05-08
Recalling firm: Merz North America, Inc.
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.
Product code: MIX System, Vocal Cord Medialization
Reason for recall: The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Letters were issued 11/4/2015 to consignees. The letter informs the consignees that they can continue to safely use the affected products by referring to the USE BEFORE date. They letter does not require for any product to be returned. Also, there is no sub-recall required as the product was not distributed to distributors or wholesalers.
Quantity in commerce: 7,715 units
Distribution: Distributed US (nationwide) including the Virgin Islands and South Africa.
Product codes and lots: Lot Number 100079214, 100077099, 100077251, 100077252, 100077253, 100078692, 100079598, 100080204, 100081409, 100081577, 100082304, 100082438, 100083371, 100083875, 100083932

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0367-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0367-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-09	2015-12-03
Z-0368-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-09	2015-12-03

Product code MIX

K060815Class IIJuliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc. / cleared 2006-04-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)