FDAFDA · Food and drugs·Recall number Z-0607-2018
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.
Published February 21, 2018 · Recall initiated: December 11, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Contamination with Methylbacterium thiocyanatum
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sanofi Genzyme
- Distributor
- US Nationwide distribution(36 states)
- Lot
- Lot Number: 7RSL021 Expiration Date: 2020-05-31
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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