Device 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.
Z-0607-2018
Product summary
- Firm
- Sanofi Genzyme
- Event
- Event 78792
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,380 units
- Official record key
device-enforcement:Z-0607-2018
Official wording
Reason: Contamination with Methylbacterium thiocyanatum
Code information: Lot Number: 7RSL021 Expiration Date: 2020-05-31
Distribution pattern: US Nationwide distribution(36 states)
Derived failure modes
-
Unknown
Contamination with Methylbacterium thiocyanatum