Food, drugs, devices › ConMed Corporation

Device recall: Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 cm Catalog Number: 60-9510-001,

Q: Why was this device recalled?

FDA's record gives the reason for recall as: "ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns."

Q: What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Q: Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution."

Q: Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 7 Apr 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Q: Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

FDA enforcement event 67610 · Class II · initiated 20 Feb 2014 · status Terminated · terminated 7 Apr 2017

DeviceVoluntary: Firm initiated1 product recordUtica, NY

FDA enforcement event 67610 is a device recall by ConMed Corporation of Utica, NY, initiated 20 Feb 2014 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.

Status: Terminated, terminated 7 Apr 2017. Initiation: voluntary: firm initiated. ConMed Corporation has 24 enforcement events on this register, with a median of 2 product records per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

ConMed Corporation, Utica, NY.

Reason for recall

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

Distribution

"Worldwide Distribution."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1839-2014	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…	12,653 units (10,769 domestically & 1,884 internationally)	Class II	Terminated	25 Jun 2014

Context

91%of 2014 device events are Class II1,176 events that year

1product record in this eventfirm median: 2

24events on this register for the firm

Other enforcement events for ConMed Corporation

Initiated	Product (first record)	Type	Class	Records
14 Jul 2026	CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT Suture Anchor	Device	Class II	1
14 May 2026	ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Length. Catalog Number: iASB5-150. 6 units pe	Device	Class II	11
18 Nov 2022	Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187	Device	Class II	1
26 Mar 2021	INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 a	Device	Class II	2
12 Nov 2020	Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction.	Device	Class II	2
21 Mar 2019	ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: TRS100SB2 The Anchor Tissue Retrieval System	Device	Class II	6
23 Feb 2018	MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use i	Device	Class II	5
19 Jun 2017	STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administration Sets and Extension Sets (Catalog Numb	Device	Class II	2
17 Apr 2017	Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be use	Device	Class II	1
28 Feb 2017	Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurg	Device	Class II	5

All 24 events for ConMed Corporation

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 7 Apr 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.