Z-0367-2016 Class II Terminated
FDA device recall Z-0367-2016 was initiated by Merz North America, Inc. on Oct 26, 2015 and is designated Class II. 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. The recall status is terminated (terminated May 8, 2017). Affected quantity: 7,715 units.
Recall details
- Product Type
- Devices
- Report Date
- Dec 9, 2015
- Initiation Date
- Oct 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0367-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026