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

FDA device recall Z-0986-2024 · posted 2024-02-06 · Open, Classified

Recall details

Recalling firm

Covidien LP

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

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.

Root cause

Process control

Status

Open, Classified

Product code

OCW

Quantity affected

54 units

Distribution

US Nationwide distribution in the states of CA, CO, FL, IL, TX.

Date initiated

2023-11-16

Date posted

2024-02-06

Location

Mansfield, MA

Related 510(k) clearances