Recall Z-0607-2018— Sanofi Genzyme
Class II · Terminated
Class II FDA medical device recall by Sanofi Genzyme, initiated 2017-12-11, terminated 2023-04-03. FDA's recall record names no specific 510(k) clearance for this event. 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: Contamination with Methylbacterium thiocyanatum.
- Recalling firm
- Sanofi Genzyme
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-11
- Terminated
- 2023-04-03
- Firm location
- Cambridge, MA, United States
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.