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Open, Classified

Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO1575 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No

FDA Recall Z-2902-2026 · Posted 2026-08-06

Recalling FirmTISSIUM SA
Recall StatusOpen, Classified
Product CodeSFD
Date Initiated2026-06-15

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.

Firm Action

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

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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