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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 FirmMarch 24, 2022
Create DateMay 10, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1053-2022
Recall Event ID 90016
510(K)NumberK122898 
Product Classification Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
ProductSTRATAFIX 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
ActionA 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 Commerce2808 (all OUS)
DistributionInternational distribution in the country of China.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GAM
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