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U.S. Department of Health and Human Services

Class 2 Device Recall SynviscOne

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  Class 2 Device Recall SynviscOne see related information
Date Initiated by Firm December 11, 2017
Create Date February 14, 2018
Recall Status1 Open3, Classified
Recall Number Z-0607-2018
Recall Event ID 78792
PMA Number P940015 
Product Classification Acid, hyaluronic, intraarticular - Product Code MOZ
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.
Code Information Lot Number: 7RSL021 Expiration Date: 2020-05-31
Recalling Firm/
Manufacturer
Sanofi Genzyme
500 Kendall St
Cambridge MA 02142-1108
For Additional Information Contact Sanofi Customer Service
800-633-1610
Manufacturer Reason
for Recall
Contamination with Methylbacterium thiocyanatum
FDA Determined
Cause 2
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 in Commerce 12,380 units
Distribution US Nationwide distribution(36 states)
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = MOZ and Original Applicant = GENZYME CORP.
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