FDAClass IIFebruary 21, 2018

Synvisc-One ¿ recall: Contamination

Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Product Usage: A elastoviscous high molecular weight fluid containing hylan A and…

Why was Synvisc-One ¿ recalled?

Contamination with Methylbacterium thiocyanatum

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: 7RSL021 Expiration Date: 2020-05-31

Product
Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Product Usage: A elastoviscous high molecular weight fluid containing hylan A and…
Recalling firm
Sanofi Genzyme
Quantity
12,380 units
Distribution
US Nationwide distribution(36 states)
Recall date
February 21, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls