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U.S. Department of Health and Human Services

Class 2 Device Recall STRATAFIX Spiral PDS Plus Knotless Tissue Control Device

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  Class 2 Device Recall STRATAFIX Spiral PDS Plus Knotless Tissue Control Device see related information
Date Initiated by Firm August 13, 2019
Date Posted October 04, 2019
Recall Status1 Terminated 3 on February 11, 2021
Recall Number Z-0048-2020
Recall Event ID 83715
510(K)Number K182873  
Product Classification Suture, surgical, absorbable, polydioxanone - Product Code NEW
Product STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle
Product code: SXPP1B401 suture
Code Information Lot # MMH401 GTIN: 10705031236042
Recalling Firm/
Manufacturer		 Ethicon, Inc.
Us Highway 22 West
Somerville NJ 08876
For Additional Information Contact Ethicon Customer Support Cente
877-384-4266
Manufacturer Reason
for Recall		 The product does not meet certain internal strength testing specifications.
FDA Determined
Cause 2		 Under Investigation by firm
Action Ethicon sent a letter on 8/30/2019. 1. Examine your inventory quarantine the recalled product 2. Do not open the foil pouches to conform contents 3. Complete the Business Reply Form (BRF)confirming receipt of this notice and fax or email it to Stericycle at 888-877-7241 or Ethicon5647@stericycle.com within three (3) business days. 4. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Stericycle 5. Distributors are required to return unused impacted STRATAFIX" Spiral PDS" Plus Knotless Tissue Control Devices subject to this recall that are in their inventory immediately. To receive replacement product, customers must return product subject to this recall by November 30, 2019. Any non-affected product or impacted product returned after the date specified will not be replaced. If you require any assistance with returning product, please contact Stericycle at 888-759-6910 and reference Event# 5647. If you have additional questions regarding this recall or to report any customer complaints, please contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 8:00 AM to 6:00 PM ET.
Quantity in Commerce 852 each
Distribution States: IN MD AR IL GA TN NJ PA NC CA OK CO KS UT KY WA OH OR OUS: Australia Hong King India Japan Korea Singapore Thailand United 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 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 = NEW and Original Applicant = Ethicon, Inc.
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