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U.S. Department of Health and Human Services

Class 2 Device Recall Coated VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture

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  Class 2 Device Recall Coated VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture see related information
Date Initiated by Firm April 20, 2010
Date Posted May 18, 2010
Recall Status1 Terminated 3 on July 19, 2011
Recall Number Z-1608-2010
Recall Event ID 55428
510(K)Number K033746  K962480  K944110  
Product Classification Suture, absorable, synthetic, polyglycolic acid - Product Code GAM
Product Coated VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture, Undyed.

Intended use: Soft Tissue approximation.
Code Information Sales code Lot# mfg date Exp date VR496 ZE9CZME0 04-Jun-07 2012-05 VR944 ZE9GLZD0 05-Jun-07 2012-05 VR932 ZE9HGDG0 06-Jun-07 2012-05 VR496 ZE9GHCE0 06-Jun-07 2012-05 VR844 ZE9GSWE0 07-Jun-07 2012-05 VR845 ZE9HCMG0 07-Jun-07 2012-05 VR917 ZE9GWPD0 30-May-07 2012-05 VR496 ZE9HGGE0 12-Jun-07 2012-05 VR834 ZE9HPHG0 11-Jul-07 2012-05 VR935 ZE9JGGE0 06-Jun-07 2012-05 VR493 ZE9JTHE0 15-Jun-07 2012-05 VR416 ZE9KHXC0 22-Jun-07 2012-05 VR494 ZE9KLTE0 14-Jun-07 2012-05 VR417 ZE9JLQD0 06-Jun-07 2012-05 VR496 ZE9JZTE0 27-Jun-07 2012-05 VR493 ZG9CSPE0 27-Jun-07 2012-06 VR497 ZE9KPLE0 20-Jun-07 2012-05 VR496 ZE9KCGE0 25-Jun-07 2012-05 VR944 ZG9BJTD0 28-Jun-07 2012-06 VR834 ZG9DHJG0 03-Jul-07 2012-06 VR496 ZG9CLZE0 26-Jun-07 2012-06 VR426 ZG9CWJE0 26-Jun-07 2012-06 VR490 ZG9DMTD0 03-Jul-07 2012-06 VR945 ZG9DTKG0 29-Jun-07 2012-06 VR845 ZG9GDDG0 03-Jul-07 2012-06 VR496 ZG9DHPE0 03-Jul-07 2012-06 VR835 ZG9GLMG0 29-Jun-07 2012-06 VR844 ZG9GJQE0 03-Jul-07 2012-06 VR931 ZG9GJSH0 03-Jul-07 2012-06 VR932 ZG9HZLG0 03-Jul-07 2012-06 VR497 ZG9GZRE0 03-Jul-07 2012-06 VR944 ZG9GZSD0 29-Jun-07 2012-06 VR917 ZG9JBXD0 11-Jul-07 2012-06 VR945 ZG9HQWG0 10-Jul-07 2012-06 VR497 ZG9JRBE0 11-Jul-07 2012-06 VR416 ZG9KHSC0 11-Jul-07 2012-06 VR493 ZG9JTSE0 12-Jul-07 2012-06 
Recalling Firm/
Manufacturer		 Ethicon, Inc.
US Highway 22 West
Somerville NJ 08876
For Additional Information Contact Christiana Bielinski
908-218-2553
Manufacturer Reason
for Recall		 Channels in the packaging seal that can lead to suture degradation and loss of packaging integrity. Recall Z-0021-2009 was initiated in 2008. Ethicon had decided to recall all sutures product during the may to June 2007 timeframe.
FDA Determined
Cause 2		 Other
Action "Expansion of 2008 Voluntary Recall" notification letters dated April 20, 2010 were sent by second day UPS to customers, distributors, Materials Managers, Director of Surgical Services, and Directors of Risk Management. The letters state that the expansion includes 37 lots of products. The letters describe the product, problem and action t to be taken by customers. The customers were instructed to immediately discontinue use of any of the affected product and to remove from all inventory and returned to Stericycle. If they are not returning product, they should mail the enclosed business reply card to Stericycle. The customers should notify their end customers of this recall. If their end customers have the affected product they should first call 1-888-345-0483 to get appropriate shipping labels. THIS RECALL EXPANSION ONLY IMPACTS THE VICRYL RAPID SUTURE. THIS DOES NOT INCLUDE THE VICRYL* ADN VICRYL* PLUS PRODUCTS. Please don't hesitate to contact Christie Bielinski directly at 908-218-2553 or via email at cbielinsi@its.jnj.com should you have any questions or require additional information.
Quantity in Commerce 118332 eaches were sent to the US Distribution Center, of which 69936 eaches were shipped to primary consignees.
Distribution Worldwide distribution: USA and Austria, Belgium, Canada, Chile, China, Czech Republic, Egypt, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Malaysia, Middle East, Netherlands Antilles, New Zealand, Poland, Portugal, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom
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.
510(K) Database 510(K)s with Product Code = GAM and Original Applicant = ETHICON, INC.
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