PROLARYN Injectable Implant 1.0 cc Gel recall
PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying…
Why was PROLARYN Injectable Implant 1.0 cc Gel recalled?
The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number 100079214, 100077099, 100077251, 100077252, 100077253, 100078692, 100079598, 100080204, 100081409, 100081577, 100082304, 100082438, 100083371, 100083875, 100083932
- Product
- PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying…
- Recalling firm
- Merz North America, Inc.
- Quantity
- 7,715 units
- Distribution
- Distributed US (nationwide) including the Virgin Islands and South Africa.
- Recall date
- December 9, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)