Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2075 Software Version: N/A Produc

FDA device recall Z-2904-2026 · posted 2026-08-06 · Open, Classified

Recall details

Recalling firm

TISSIUM SA

Reason for recall

Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.

Action taken

On June 25, 2026, the firm began notifying consignees via direct visit by medical representatives to deliver the Customer Recall Notification Letter in person. Representatives removed affected units from customer shelves, collected completed response forms, and provided conforming replacement product on the same day.

Root cause

Incorrect or no expiration date

Status

Open, Classified

Product code

SFD

Distribution

US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.

Date initiated

2026-06-15

Date posted

2026-08-06

Location

France