FDA recall Z-0607-2018

Sanofi Genzyme · Class II · 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.

Reason for recall

Contamination with Methylbacterium thiocyanatum

Distribution

US Nationwide distribution(36 states)

Key facts

Status
Terminated
Initiation date
2017-12-11
Report date
2018-02-21
Termination date
2023-04-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0607-2018