Sanofi Genzyme Recall: Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Pro
Sanofi Genzyme Recall: Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Pro is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Sanofi Genzyme; Product: Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Product Usage: A elastoviscous high molecular weight fluid
| Recalling firm | Sanofi Genzyme |
|---|---|
| Product | 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. |
| Reason for recall | Contamination with Methylbacterium thiocyanatum |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | US Nationwide distribution(36 states) |
| Recall initiated | 20171211 |
| Recall number | Z-0607-2018 |
| Category | device |
| State | MA |
| Country | United States |
$29/mo
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