Reported Dec 9, 2015 · Terminated
PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical…
Merz North America, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merz North America, Inc. · 6501 Six Forks Rd · Raleigh, NC · 27615-6515
Is this the product you have?
- PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation.
- Lot codes and dates
Lot Number 100079214100077099100077251100077252100077253100078692100079598100080204100081409100081577100082304100082438100083371100083875100083932
- Amount recalled
- 7,715 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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