ConMed Recalls Arthroscopic Energy 50 Probe Due to Programming Error
ConMed is recalling 276 Arthroscopic Energy 50 Probes with Suction because a programming error may generate excess heat, increasing the risk of tissue damage during surgery.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect that increases the probability of tissue damage (risk of harm), but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ConMed Corporation is recalling 276 units of the Arthroscopic Energy 50 Probe with Suction (Catalog number: AES-50S). The device is used for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic surgical procedures.
The recall is due to a probe programming error. The incorrect program can generate more heat at the surgical site, resulting in an elevated probability of tissue damage.
The affected devices were distributed worldwide, with US distribution in the states of Florida and Ohio, and in the country of Spain. The affected lot codes are 1412161, 1410201, 1410271, 1412121, and 1412081. Healthcare facilities should stop using the affected devices and contact ConMed Corporation for further instructions.
The recalled product
- 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.
- Manufacturer
- ConMed Corporation
- Hazard
- Affected units
- 276
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 1412161
- 1410201
- 1410271
- 1412121
- and 1412081
Distribution
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