FDAFDA · Food and drugs·Recall number Z-0368-2016
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.
Published December 9, 2015 · Recall initiated: October 26, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Merz North America, Inc.
- Distributor
- Distributed US (nationwide) including the Virgin Islands and South Africa.
- Lot
- Lot Number 100076901, 100077013, 100077249, 100077250, 100078691, 100079054, 100079213, 100079597, 100079954, 100080082, 100081008, 100081401, 100081573, 100081916, 100082248, 100082468, 100082695, 100082729, 100083126, 100083785, 100083934
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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