Cambridge, MA, United States
Sanofi Genzyme recalls
1 recall recorded since 2018, most recently on 11 December 2017. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 11 December 2017
- Terminated
- 3 April 2023
- Reason
- Contamination with Methylbacterium thiocyanatum
- Distribution
- US Nationwide distribution(36 states)
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0607-2018
- 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 administe
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.