Reported Feb 21, 2018 · Terminated

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

Sanofi Genzyme

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Sanofi Genzyme · 500 Kendall St · Cambridge, MA · 02142-1108

Is this the product you have?

    • Synvisc-One ¿ (hylan G-F 20)
    • 6mL delivered
  • from a 10mL syringe Product UsageA 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
Lot codes and dates
  • Lot Number7RSL021
  • Expiration Date2020-05-31
Amount recalled
12,380 units

Where it was sold

  • Nationwide

Why it was recalled

Contamination with Methylbacterium thiocyanatum

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 3, 2023 · Data as of Sep 19, 5:22 PM UTC

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