Sanofi Genzyme: Medical Device Recall in 2018 - (Recall #: Z-0607-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: December 11, 2017

Date Posted: February 21, 2018

Recall Number: Z-0607-2018

Event ID: 78792

Reason for Recall:

Contamination with Methylbacterium thiocyanatum

Status: Terminated

Product Quantity: 12,380 units

Code Information:

Lot Number: 7RSL021 Expiration Date: 2020-05-31

Distribution Pattern:

US Nationwide distribution(36 states)

Voluntary or Mandated:

Voluntary: Firm initiated