Recall Weekly
Moderate riskFDA DeviceClass II

Tissium COAPTIUM CONNECT recalled for unsubstantiated shelf life

Tissium SA is recalling COAPTIUM CONNECT, a nerve repair device, because its labeled 36-month shelf life is not supported by real-time data. The devices will be relabeled with a 26-month shelf life. Using the device past its validated shelf life may cause it to break during surgery, which could make it unusable; the worst-case outcome would be revision surgery.

From the FDA notice · Read the official notice ↗

What to do

  1. Set aside affected devices and do not use them beyond the revised 26-month shelf life.
  2. Identify affected devices by model NCOCO6010, UDI-DI 03760279380209, and lot numbers 250700051, 251000044, or 251000045.
  3. The notice does not say how to get relabeled devices; contact Tissium SA directly.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO6010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 7 products — see all of them.

Details

Illnesses reported
None reported
Manufactured in
74 Rue Du Faubourg Saint-Antoine, Paris 12e Arrondissement, France
Classification
Class II
Recall number
Z-2908-2026

In the FDA's words

Description
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO6010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No 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. Lot Code: Model No NCOCO6010; UDI-DI ¿03760279380209; Lot Numbers 250700051, 251000044, and 251000045 Distribution: US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.
Hazard
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.

7 products in this recall

The agency lists each product separately. Check every one you might have.

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