Merz North America, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0368-2016)

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 PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Model No. 8044M0K5. An injectable implant used to treat vocal fold insufficiency.

Product Classification:

Class II

Date Initiated: October 26, 2015

Date Posted: December 9, 2015

Recall Number: Z-0368-2016

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: 9,439 units

Code Information:

Lot Number 100076901, 100077013, 100077249, 100077250, 100078691, 100079054, 100079213, 100079597, 100079954, 100080082, 100081008, 100081401, 100081573, 100081916, 100082248, 100082468, 100082695, 100082729, 100083126, 100083785, 100083934

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated