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Recall Observatory FDA recall evidence

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

October 26, 2015

Class II

Product summary

Firm
Merz North America, Inc.
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

    reason.labeling_packaging · v1.0.0

    label is incorrect