Z-0607-2018Class II

Synvisc-One (hylan G-F 20), 6mL delivered from a 10mL syringe

Name: Z-0607-2018 Synvisc-One (hylan G-F 20), 6mL delivered from a 10mL syringe
Creator: Sanofi Genzyme
Published: 2017-12-11
License: https://open.fda.gov/license/

Sanofi Genzyme Corp. / initiated 2017-12-11 / Terminated / root cause: manufacturing process

FDA source

Sanofi Genzyme began a recall of 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... on 2017-12-11. FDA classified it as Class II and gives the reason as "Contamination with Methylbacterium thiocyanatum". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0607-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-11
Posted: 2018-02-14
Terminated: 2023-04-03
Recalling firm: Sanofi Genzyme Corp.
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.
Product code: MOZ Acid, Hyaluronic, Intraarticular
Reason for recall: Contamination with Methylbacterium thiocyanatum
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: On December 11, 2017 Sanofi Genzyme distributed URGENT VOLUNTARY DEVICE RECALL notices and reply cards to their customers via courier service. Customers were advised to inspect inventory, immediately discontinue use and return all affected product. On December 19, 2017 Sanofi Genzyme distributed a 2nd notice titled DEVICE RECALL UPDATE NOTICE (2 of 3) notifying customers that the isolated bacterial organism was Methylbacterium thiocyanatum. On December 22, 2017 Sanofi Genzyme distributed a 3rd notice titled DEVICE RECALL UPDATE NOTICE (3 of 3) which included antibiotic sensitivity analysis guidance for the isolated organism. Customers who wish to return product should contact GENCO Pharmaceutical Services at 1-855-838-5782 for a recalled product return kit. Customers are encouraged to complete and return the Business Reply Card via fax to 1-414-459-8791 or via email to [email protected]. Sanofi Genzyme will issue you a credit or replacement product upon receipt of the recalled product by GENCO. All questions of a medical or clinical nature should be directed to Sanofi Medical Information Services in the U.S. at 1-800-633-1610, option 1. Sanofi US Customer service can be reached at 1-800-633-1610 option 7 then 4.
Quantity in commerce: 12,380 units
Distribution: US Nationwide distribution(36 states)
Product codes and lots: Lot Number: 7RSL021 Expiration Date: 2020-05-31

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0607-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0607-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-13

Product code MOZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)