Recall Weekly
Moderate riskFDA DeviceClass II

Tissium Coaptium Connect recalled for unverified shelf life

Tissium is recalling Coaptium Connect nerve repair devices, model NCOCO5010, 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. Use beyond the validated shelf life may cause the device to break during surgery, and the worst-case outcome would be revision surgery.

From the FDA notice · Read the official notice ↗

What to do

  1. Set aside affected lots and do not use them beyond the revised 26-month shelf life.
  2. Identify affected devices by model NCOCO5010, UDI-DI 03760279380179, and lot numbers 250700050, 251000043, 260300048, 260300049, or 260300050.
  3. The notice doesn't say how to get relabeled devices or replacements; contact Tissium SA for next steps.
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: NCOCO5010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
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-2907-2026

In the FDA's words

Description
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 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 NCOCO5010; UDI-DI 03760279380179; Lot Numbers 250700050, 251000043, 260300048, 260300049, and 260300050 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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