Device product
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.
Z-0368-2016
Product summary
- Event
- Event 72591
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,439 units
- Official record key
device-enforcement:Z-0368-2016
Official wording
Reason: The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
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.
Derived failure modes
-
Labeling or packaging
label is incorrect