Recall Weekly
Moderate riskFDA DeviceClass II

Tissium COAPTIUM Connect nerve repair device recalled for shelf life

The 36-month shelf life on COAPTIUM Connect peripheral nerve repair devices is not substantiated by real-time data, so 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 and become unusable; the worst-case outcome would be revision surgery. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Check lots 250700041 and 251000032 (Model NCOCO1510, UDI-DI 03760279380070) against your inventory and set aside any devices from these lots.
  2. Do not use affected devices beyond the revised 26-month shelf life.
  3. Contact Tissium SA for the relabeling and any return or replacement details; the notice does not specify a remedy.
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: NCOCO1510 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: N/A
Sold in
Nationwide
Made for
All ages (under 100 years)

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-2901-2026

In the FDA's words

Description
Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number: NCOCO1510 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: N/A 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 NCOCO1510; UDI-DI 03760279380070; Lot Numbers 250700041 and 251000032 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

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