FDA-Device2018-02-21Class II
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.
Sanofi Genzyme
Hazard
Contamination with Methylbacterium thiocyanatum
Sold states
US Nationwide distribution(36 states)
Affected count
12,380 units
Manufactured in
500 Kendall St, Cambridge, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0607-2018Don't want to check this manually?
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