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U.S. Department of Health and Human Services

Class 2 Device Recall AbsorbaTack" Absorbable Fixation Device

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  Class 2 Device Recall AbsorbaTack" Absorbable Fixation Device see related information
Date Initiated by Firm November 16, 2023
Date Posted February 06, 2024
Recall Status1 Open3, Classified
Recall Number Z-0986-2024
Recall Event ID 93722
510(K)Number K090470  
Product Classification Endoscopic tissue approximation device - Product Code OCW
Product AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm-
-intended for fixation of prosthetic material to soft tissue in minimally invasive and open surgical hernia repair procedures
Model ABSTACK30
Code Information GTIN 20884523006527 Lot number: N3J1860Y
Recalling Firm/
Manufacturer		 Covidien LP
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information Contact Technical Service
800-962-9888 Ext. 2
Manufacturer Reason
for Recall		 Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromising the product sterility
FDA Determined
Cause 2		 Process control
Action Medtronic issued Urgent Medical Device Recall Letter and Customer Acknowledgement Form to each consignee via mail beginning 16 November 2023. Letter states reason for recall, health risk and action to take: Identify and quarantine all unused and non-expired affected lot N3J1860Y of the ModelABSTACK30 AbsorbaTack" Absorbable Fixation Device listed above. See attachment A forguidance on identifying potentially affected devices. "Return all unused product from the affected lot in your inventory to Medtronic. Please contactrs.covidienfeedbackcustomerservice@medtronic.com for the Return Good Authorization (RGA). "In addition, please complete and return the enclosed Customer Confirmation Form tors.gmbfcamitg@medtronic.com even if you do not have unused inventory. "Pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected product has been transferred or distributed. If you have any questions regarding this communication, please contact your Medtronic Representative or Customer Service at 800-962-9888.
Quantity in Commerce 54 units
Distribution US Nationwide distribution in the states of CA, CO, FL, IL, TX.
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 = OCW and Original Applicant = COVIDIEN
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