Home › SAIMA GLOBAL FARMA S.L. › SYNVISC ONE
SYNVISC ONE
SAIMA GLOBAL FARMA S.L. · Model 58468-0090-3 · UDI-DI 08437027710049
MOZ
Prescription
0
510(k) clearances
8,423
Adverse events (310 deaths)
2
Recalls
25
Facilities
Description
SYNVISC ONE (hylan G-F 20) is an elastoviscous high molecular weight fluid containing hylan A and hylan B polymers made from hyaluronan. Hyaluronan acts as a lubricant and shock absorber in the joint. SYNVISC ONE is used to relieve knee pain due to osteoarthritis in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-12-11 | Sanofi Genzyme | Contamination with Methylbacterium thiocyanatum |
| 2010-04-16 | Ferring Pharmaceuticals Inc | Out of Specification results for molecular weight or viscosity through the established expiration date. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.