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U.S. Department of Health and Human Services

Class 3 Device Recall Euflexxa (1 sodium hyaluronate)

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  Class 3 Device Recall Euflexxa (1 sodium hyaluronate) see related information
Date Initiated by Firm April 16, 2010
Date Posted May 21, 2010
Recall Status1 Terminated 3 on July 27, 2010
Recall Number Z-1635-2010
Recall Event ID 55407
PMA Number P010029 
Product Classification Acid, hyaluronic, intraarticular - Product Code MOZ
Product Euflexxa (1% sodium hyaluronate). Pre-filled syringe, Rx only, 3 syringes per carton; Manufactured by Ferring Pharmaceuticals In, Parsippany, NJ 07054;
Manufactured by Bio-Technology General (Israel Ltd. Be er Tuvia, Kiryat Malachi 83104 Israel.

Indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.
Code Information Lot Numbers: RC0101A, Exp. 5/2010; RC0102A, Exp. 5/2010; RC0107A, Exp 5/2010; RC0114A, Exp 5/2010; RC0118A, Exp 6/2010; RC0122A, Exp 6/2010; RC0123A, Exp 6/2010; RC0127A, Exp 6/2010; and RC0131A, Exp 6/2010.
Recalling Firm/
Manufacturer		 Ferring Pharmaceuticals Inc
4 Gatehall Dr Fl 3rd
Parsippany NJ 07054-4518
For Additional Information Contact Paul Stapel
973-796-1636
Manufacturer Reason
for Recall		 Out of Specification results for molecular weight or viscosity through the established expiration date.
FDA Determined
Cause 2		 Process control
Action Ferring Pharmaceuticals issued a "Medical Device Recall" notification dated April 16, 2010 by Federal Express to all distributors, retail pharmacies and physicians who received the product. Consignees were asked to stop distribution, return affected product to the firm and fax a completed Product Inventory Form to the firm. For further information, contact Ferring Pharmaceuticals at 1-973-796-1600 or via fax at 1-973-796-1660.
Quantity in Commerce 29,376 cartons with 3 syringes per carton.
Distribution Nationwide distribution.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MOZ and Original Applicant = FERRING PHARMACEUTICALS, INC.
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