Merz North America, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0367-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: October 26, 2015

Date Posted: December 9, 2015

Recall Number: Z-0367-2016

Event ID: 72591

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.

Status: Terminated

Product Quantity: 7,715 units

Code Information:

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

Distribution Pattern:

Distributed US (nationwide) including the Virgin Islands and South Africa.

Voluntary or Mandated:

Voluntary: Firm initiated