Merz North America, Inc. recalls PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstruc…
- Recall date
- October 26, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0367-2016
- FDA classification
- Class II
- Brand / firm
- Merz North America, Inc.
- Sold / distributed
- Distributed US (nationwide) including the Virgin Islands and South Africa.
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
Get recall alerts
Free email alert whenever Merz North America, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Merz North America, Inc.