Z-1839-2014Class II

Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 cm Catalog Number...

Name: Z-1839-2014 Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 cm Catalog Number...
Creator: ConMed Corporation
Published: 2014-02-20
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2014-02-20 / Terminated / root cause: design

FDA source

ConMed Corporation began a recall of 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... on 2014-02-20. FDA classified it as Class II and gives the reason as "ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1839-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-20
Posted: 2014-06-20
Terminated: 2017-04-07
Recalling firm: ConMed Corporation
Product: 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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns.
Root cause tag: design
FDA root cause: Device Design
Action: On February 20, 2014 and February 28, 2014 ConMed Corporation distributed Urgent Medical Device Correction notices to their domestic and foreign customers via FedEx Priority. The notice was generated by ConMed for information purposes only. Customers are to ensure that the jaws of the energy vessel sealing device does not come in contact with unintended tissue, surfaces, or objects until the jaws have cooled sufficiently. Customers who have further distributed this product, please forward a copy of the correction notice to the recipient as appropriate. Customers will questions should contact ConMed Regulatory Affairs at (315) 624-3237 or by email at [email protected].
Quantity in commerce: 12,653 units (10,769 domestically & 1,884 internationally)
Distribution: Worldwide Distribution.
Product codes and lots: all lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1839-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1839-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-25	2014-06-19

Product code GEI

K101534Class IIConmed Altrus Thermal Tissue Fusion SystemConmedcorp / cleared 2010-11-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)