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U.S. Department of Health and Human Services

Class 2 Device Recall STRATAFIX Spiral PGAPCL Knotless Tissue Control Device (Uni Directional)

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  Class 2 Device Recall STRATAFIX Spiral PGAPCL Knotless Tissue Control Device (Uni Directional) see related information
Date Initiated by Firm March 24, 2022
Create Date May 10, 2022
Recall Status1 Open3, Classified
Recall Number Z-1053-2022
Recall Event ID 90016
510(K)Number K122898  
Product Classification Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
Product STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].
Code Information Lot AAHM529, UDI(01)10705031228054(20)12(17)260331(10)AAHM529 Lot AAHQ049, UDI (01)10705031228047(20)12(17)260430(10)AAHQ049
Recalling Firm/
Manufacturer		 Ethicon, Inc.
Us Highway 22 West
Somerville NJ 08876
For Additional Information Contact
908-218-0707
Manufacturer Reason
for Recall		 Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
FDA Determined
Cause 2		 Employee error
Action A translated notification letter was mailed to customers in China on 03/24/2022. Customers are advised to no longer use or distribute recalled product. Arrange returns through your upstream distributor or Johnson & Johnson Medical (Shanghai) Ltd. All customers and sub-distributors are to complete and submit the acknowledgement form. Contact your local sales representative with questions or contact 1-877-ETHICON.
Quantity in Commerce 2808 (all OUS)
Distribution International distribution in the country of China.
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.
510(K) Database 510(K)s with Product Code = GAM and Original Applicant = SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
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