Z-0607-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2018
- Initiation Date
- December 11, 2017
- Termination Date
- April 3, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,380 units
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
Distribution Pattern
US Nationwide distribution(36 states)
Code Information
Lot Number: 7RSL021 Expiration Date: 2020-05-31