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.
Reported: December 9, 2015 Initiated: October 26, 2015 #Z-0368-2016
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.
Details
- Recalling Firm
- Merz North America, Inc.
- Units Affected
- 9,439 units
- Distribution
- Distributed US (nationwide) including the Virgin Islands and South Africa.
- Location
- Raleigh, NC
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Merz North America, Inc.. Units affected: 9,439 units.
Why was this product recalled? ▼
The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 9, 2015. Severity: Moderate. Recall number: Z-0368-2016.
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