Z-1681-2012

Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 5 mm O.D., 16 cm Shaft, Catalog Number 60-9520-001...

Name: Z-1681-2012 Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 5 mm O.D., 16 cm Shaft, Catalog Number 60-9520-001...
Creator: ConMed Electrosurgery
Published: 2012-05-07
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2012-05-07 / Terminated / root cause: manufacturing process

FDA source

ConMed Electrosurgery began a recall of Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 5 mm O.D., 16 cm Shaft, Catalog Number 60-9520-001, Sterile/EO. The Altrus Thermal Tissue Fusion System... on 2012-05-07. The reason FDA records is "The devices were distributed prior to the firm completing performance qualifications for their package sealing and adhesive bonding". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1681-2012
Status: Terminated
Initiated: 2012-05-07
Posted: 2012-05-29
Terminated: 2012-06-05
Recalling firm: ConMed Corporation
Product: Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 5 mm O.D., 16 cm Shaft, Catalog Number 60-9520-001, Sterile/EO. The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: The devices were distributed prior to the firm completing performance qualifications for their package sealing and adhesive bonding.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: ConMed Electrosurgery sent an "URGENT: DEVICE RECALL" letter dated May 2, 2012 to all affected customers. The letter identifies the product, problem,and actions to be taken by the customers. The letter instructs customers to review their inventory and to complete and return a Business Reply Form via fax to 303-699-9854.
Quantity in commerce: 18 units
Distribution: Class II Recall-Nationwide Distribution-including the states of OH, GA, IL, PA, AZ, KY, FL, NY, MO, TN, TX, AL, IN, SC, MD, CT, NJ, and CA.
Product codes and lots: Lot codes: 11AHB005, 11DHB005.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)