medical MODERATE Updated 2026-08-12

TISSIUM SA recalls Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT

See all recalls from TISSIUM SA →

Recalled Product

Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No

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Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Code: Model No NCOCO2010; UDI-DI 03760279380094; Lot Number 250700042, 251000033, and 251000034

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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