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Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Product Usage: A elastoviscou...

FDA Recall #Z-0607-2018 — Class II — December 11, 2017

Recall #Z-0607-2018 Date: December 11, 2017 Classification: Class II Status: Terminated

Product Description

Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Product Usage: A elastoviscous high molecular weight fluid containing hylan A and hylan B polymers produced from chicken combs. Synvisc-One is administered as a single intra-articular injection. Synvisc-One is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.

Reason for Recall

Contamination with Methylbacterium thiocyanatum

Recalling Firm

Sanofi Genzyme — Cambridge, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

12,380 units

Distribution

US Nationwide distribution(36 states)

Code Information

Lot Number: 7RSL021 Expiration Date: 2020-05-31

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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