Integra CUSA Clarity Footswitch Recalled for Unintended Activation
Integra LifeSciences is recalling 155 CUSA Clarity footswitches because a defect may cause unintended ultrasonic fragmentation activation 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 high-risk medical device where a defect could lead to unintended activation during surgery, representing a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Integra LifeSciences Corp. is recalling 155 footswitch accessories for the CUSA Clarity Ultrasonic Tissue Ablation System. The recall covers specific lot numbers including 1885744, 1923802, 1985221, 2057996, 2109587, and 2118507. The devices were distributed worldwide, including in 33 US states and several international countries.
The recall was initiated because a faulty footswitch may result in unintended ultrasonic fragmentation activation. This failure can occur in two scenarios: first, the ultrasonic fragmentation may be inadvertently activated at start-up or initial use after the system is primed and the user enters the Main Screen; second, the fragmentation may remain activated during surgical use if the foot pedal is disengaged slowly.
The CUSA Clarity system is indicated for use in various surgical procedures, including neurosurgery, plastic and reconstructive surgery, orthopedic surgery, gynecological surgery, and thoracic surgery. Users of the affected footswitches should contact the manufacturer for further instructions on how to address the defect.
The recalled product
- Product
- Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000 Product Usage: The footswitch is a component of the CUSA Clarity Ultrasonic Surgical Aspirator System, which is indicated for use in surgical procedures where fragmentation…
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 155
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 (6)
- Lot #1885744
- Lot #1923802
- Lot #1985221
- Lot #2057996
- Lot #2109587
- Lot #2118507
Distribution
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