Recall Weekly
Moderate riskFDA DeviceClass II

Tissium Coaptium Connect recalled for unverified shelf life

Tissium SA is recalling Coaptium Connect nerve repair devices (model NCOCO2010) because the labeled 36-month shelf life is not supported by real-time data. The devices will be relabeled with a 26-month shelf life. Using a device past its validated shelf life may cause it to break during surgery, which could require revision surgery.

From the FDA notice · Read the official notice ↗

What to do

  1. Clinicians: check whether you have lots 250700042, 251000033 or 251000034 (model NCOCO2010, UDI-DI 03760279380094) and set aside any unused devices from these lots.
  2. Contact Tissium SA before using any affected device; the notice does not describe a replacement or refund.
  3. Patients with this device already implanted: contact your surgeon or care team. Do not take action on your own.
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: NCOCO2010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Sold in
Nationwide
Made for
Adults (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-2903-2026

In the FDA's words

Description
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 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 NCOCO2010; UDI-DI 03760279380094; Lot Number 250700042, 251000033, and 251000034 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.

Related topics

Expiration date errorMedical devicesSold nationwideMore from FDA Device