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U.S. Department of Health and Human Services

Class 2 Device Recall PERMAHAND Silk Sutures

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  Class 2 Device Recall PERMAHAND Silk Sutures see related information
Date Initiated by Firm October 17, 2014
Date Posted January 09, 2015
Recall Status1 Terminated 3 on August 14, 2015
Recall Number Z-0492-2015
Recall Event ID 69787
510(K)Number K946173  
Product Classification Suture, nonabsorbable, silk - Product Code GAP
Product Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.
Code Information PERMA-HAND" Silk Suture [Siliconized black braided] Product Code - 10Q06  Lots and Expiration Dates-  GPP528 JUL 2018  GPP908 JUL 2018  HAB605 JAN 2019  HAE019 JAN 2019  HAE964 JAN 2019  HAP987 JAN 2019  HBB681 JAN 2019  HBB952 JAN 2019  HBE186 JAN 2019  HCB084 JAN 2019  HCB972 JAN 2019  HCE266 JAN 2019  HCE980 JAN 2019   PERMA-HAND" Silk Suture [Siliconized black braided]  Product Code - 10Q07  Lots and Expiration Dates-  GPB984 JUL 2018  GPE919 JUL 2018  HAP822 JAN 2019  HBP781 JAN 2019  HCP953 JAN 2019  HCR677 JAN 2019
Recalling Firm/
Manufacturer		 Ethicon, Inc.
US Highway 22 West
Somerville NJ 08876
For Additional Information Contact
877-384-4266
Manufacturer Reason
for Recall		 Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products.
FDA Determined
Cause 2		 Other
Action Ethicon sent an Urgent Medical Device Recall Letter/Business Reply Form dated 10/17/2014 via UPS next day mail.
Quantity in Commerce 2,508 each
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.
510(K) Database 510(K)s with Product Code = GAP and Original Applicant = ETHICON, INC.
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