Recall Z-0205-2016— ConMed Corporation
Class II · Terminated
Class II FDA medical device recall by ConMed Corporation, initiated 2015-06-17, terminated 2017-04-11. It names one FDA 510(k) clearance: K140578. 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.. Reason: Probe programming error. The incorrect program can generate more heat at the surgical site, resulting in an elevated probability of tissue damage..
- Recalling firm
- ConMed Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-17
- Terminated
- 2017-04-11
- Firm location
- Utica, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.