Synvisc-One ¿ — Class II medical device recall Z-0607-2018
Terminated recall by Sanofi Genzyme, reported 2018-02-21, distributed nationwide. Contamination with Methylbacterium thiocyanatum
| Recall number | Z-0607-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sanofi Genzyme, Cambridge, MA, United States |
| Recall initiated | 2017-12-11 |
| Classified | 2018-02-13 |
| Reported by FDA | 2018-02-21 |
| Terminated | 2023-04-03 |
| Distributed | Nationwide (US) |
| Quantity | 12,380 units |
| Lot numbers | 7RSL021 |
| Expiration dates | 2020-05-31 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0607-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.