Z-0368-2016 Class II Terminated
FDA device recall Z-0368-2016 was initiated by Merz North America, Inc. on October 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: 9,439 units.
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
- 9,439 units
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.
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 100076901, 100077013, 100077249, 100077250, 100078691, 100079054, 100079213, 100079597, 100079954, 100080082, 100081008, 100081401, 100081573, 100081916, 100082248, 100082468, 100082695, 100082729, 100083126, 100083785, 100083934