FDA Medical Device Recalls (openFDA)
Sanofi Genzyme: 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.
- Recall number
- Z-0607-2018
- Recalling firm
- Sanofi Genzyme
- 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.
- Status
- Terminated
- Initiated
- 2017-12-11
- Posted
- not on file
- Terminated
- 2023-04-03
- Reason
- Contamination with Methylbacterium thiocyanatum
- 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 recalls@genco.com. 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
- 12,380 units
- Distribution
- US Nationwide distribution(36 states)
- Lot, serial or model codes
- Lot Number: 7RSL021 Expiration Date: 2020-05-31
- 510(k) numbers
- not on file
- PMA numbers
- ["P940015"]
- Product code
- MOZ
- Firm FEI
- 1000305672
- Firm city
- Cambridge
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28