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
This recall is currently active, issued February 6, 2024.
- Recall Initiated
- November 16, 2023
- Posted
- February 6, 2024
- Recall Number
- Z-0986-2024
- Quantity
- 54 units
- Firm Location
- Mansfield, MA
- Official Source
- View on FDA website ↗
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
Distribution
US Nationwide distribution in the states of CA, CO, FL, IL, TX.
Lot / Code Info
GTIN 20884523006527 Lot number: N3J1860Y
Root Cause
Process control
Action Taken
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.