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.
FDA Recall Z-0368-2016 · Posted 2015-12-03
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Recalling FirmMerz North America, Inc.
Recall StatusTerminated
Product CodeKHJ
Date Initiated2015-10-26
Date Terminated2017-05-08
Product Quantity9,439 units
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.
Firm Action
Letters were issued 11/4/2015 to consignees. The letter informs the consignees that they can continue to safely use the affected products by referring to the USE BEFORE date. They letter does not require for any product to be returned. Also, there is no sub-recall required as the product was not distributed to distributors or wholesalers.
Root Cause
Other
Distribution Pattern
Distributed US (nationwide) including the Virgin Islands and South Africa.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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