FDA Device recall 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…
- FDA Device
- Class II
- terminated
- Published 2018-02-21
On 2018-02-21 the FDA classified a Class II recall of Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Product Usage: A elastoviscous high molecular weight fluid containing hylan… by Sanofi Genzyme, citing contamination with Methylbacterium thiocyanatum.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0607-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-11 |
| Published | 2018-02-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Sanofi Genzyme |
| Distribution | US |
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
Identifiers
| code_info | Lot Number: 7RSL021 Expiration Date: 2020-05-31 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0607-2018%22
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