CLASS II Device recall · Reported 25 Jun 2014 · FDA Enforcement Report

Altrus Thermal Tissue Fusion Handpieces under the following recalled

ConMed is recalling Altrus Thermal Tissue Fusion Handpieces under the following specifications. The recall was initiated on 20 Feb 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesall lot codes

Quantity recalled12,653 units (10,769 domestically & 1,884 internationally)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1839-2014
FDA event ID: 67610
Recalling firm: ConMed, Utica, NY
Classification: Class II
Status: Terminated
Recall initiated: 20 Feb 2014
FDA classified: 19 Jun 2014
Reported: 25 Jun 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

20 Feb 2014	Recall initiated by company
19 Jun 2014	Classified by FDA	+119 days
25 Jun 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 cm Catalog Number: 60-9510-001, 2) 10 mm x 23 cm Catalog Number: 60-9511-001, 3) 10 mm x 36 cm Catalog Number: 60-9512-001, 4) 5 mm x 16 cm Catalog Number 60-9520-001, 5) 5 mm x 23 cm Catalog Number 60-9521-001 and 6) 5 mm x 36 cm Catalog Number 60-9522-001. Products are packaged within cartons, 6 units per carton.

Where it was distributed

Worldwide Distribution.

Questions about this recall

Why was it recalled?

ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns.

Which lots are affected?

all lot codes

Where was it sold?

Worldwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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