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SUPARTZ FX sodium hyaluronate

BIOVENTUS LLC · Model 71564444 · UDI-DI 10389130444418

MOZ Prescription

510(k) clearances

8,423

Adverse events (310 deaths)

Recalls

Facilities

Description

SUPARTZ FX (P980044) is indicated for 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. SUPARTZ FX is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from chicken combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. SUPARTZ FX is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).

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.

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Data 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.