Z-0205-2016Class II

Arthroscopic Energy 50 Probe with Suction, Catalog number: AES-50S Peoduct Usage: For resection, ablation...

Name: Z-0205-2016 Arthroscopic Energy 50 Probe with Suction, Catalog number: AES-50S Peoduct Usage: For resection, ablation...
Creator: ConMed Corporation
Published: 2015-06-17
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2015-06-17 / Terminated / root cause: software

FDA source

ConMed Corporation began a recall of Arthroscopic Energy 50 Probe with Suction, Catalog number: AES-50S Peoduct Usage: For resection, ablation, and coagulation of soft tissue and hemostasis of... on 2015-06-17. FDA classified it as Class II and gives the reason as "Probe programming error. The incorrect program can generate more heat at the surgical site, resulting in an elevated probability of tissue damage". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0205-2016
Classification: Class II
Status: Terminated
Initiated: 2015-06-17
Posted: 2015-11-03
Terminated: 2017-04-11
Recalling firm: ConMed Corporation
Product: Arthroscopic Energy 50 Probe with Suction, Catalog number: AES-50S Peoduct Usage: For resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic surgical procedures.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Probe programming error. The incorrect program can generate more heat at the surgical site, resulting in an elevated probability of tissue damage.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: On June 17, 2015 Con Med Corporation distributed Urgent Device Recall Notification Letters and Recall Reply forms to their customers via courier service. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine their inventory for any of the affected lot numbers referenced on the recall notice. If any of the recalled product are in stock, customers should discontinue the use or distribution of these items. If product was further distributed, customers should notify those individuals of this recall action. Customers with questions can call Gregory Connell at 727-399-5276 or email [email protected]. Customers should also complete and return the Recall Reply Form by mail to the address listed on the recall notice.
Quantity in commerce: 276 devices
Distribution: Worldwide - US distribution in the states of FL, OH, and the country of Spain.
Product codes and lots: 1412161, 1410201, 1410271, 1412121, and 1412081

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0205-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0205-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-11	2015-11-03

Product code GEI

K140578Class IIArthroscopic Energy SystemConmed Corporation / cleared 2014-07-23

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)