Home / Recalls / Merz North America, Inc. / Z-0367-2016

Z-0367-2016 Class II Terminated

Recalled by Merz North America, Inc. — Raleigh, NC

Recall Details

Product Type
Devices
Report Date
December 9, 2015
Initiation Date
October 26, 2015
Termination Date
May 8, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7,715 units

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.

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.

Distribution Pattern

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

Code Information

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

Other recalls by Merz North America, Inc.

  • Z-0401-2021 Class II — COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed (September 30, 2020)
  • Z-2607-2016 Class II — Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz A (May 20, 2016)
  • Z-0366-2016 Class II — Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for s (October 26, 2015)
  • Z-0368-2016 Class II — PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Inje (October 26, 2015)