FDA Medical Device · 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 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.

Class II · Terminated

Contamination with Methylbacterium thiocyanatum

Affected lots / codes — check yours against thisLot Number: 7RSL021 Expiration Date: 2020-05-31

Recalling firm: Sanofi Genzyme, Cambridge, MA
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 12,380 units
Distribution: US Nationwide distribution(36 states)
Recall initiated: December 11, 2017
Classified: February 13, 2018
Terminated: April 3, 2023
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0607-2018%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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