# FDA recall Z-0607-2018

> **Sanofi Genzyme** · Class II · device recall initiated 2017-12-11.

## 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

- **Recall number:** Z-0607-2018
- **Recalling firm:** Sanofi Genzyme
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0607-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0607-2018. Source: US FDA. Licensed CC0.

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