Z-0986-2024Class II

AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic...

Name: Z-0986-2024 AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic...
Creator: Covidien LP
Published: 2023-11-16
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2023-11-16 / Open, Classified / root cause: manufacturing process

FDA source

Covidien LP began a recall of AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in minimally invasive and... on 2023-11-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0986-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-16
Posted: 2024-02-06
Recalling firm: Medtronic, Inc.
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
Product code: OCW Endoscopic Tissue Approximation Device
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
Root cause tag: manufacturing process
FDA root cause: 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 [email protected] for the Return Good Authorization (RGA). "In addition, please complete and return the enclosed Customer Confirmation Form [email protected] 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.
Product codes and lots: GTIN 20884523006527 Lot number: N3J1860Y

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0986-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0986-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-06

Product code OCW

K090470Class IIAutosuture Protack; Tacker System; Absorbatack Fixation DevicesCovidien / cleared 2009-05-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)