Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Integra Leyla Ball Joint Clamp Recalled by Integra Limited Due to As a result of complaint investigations it was...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Integra Limited directly.
Affected Products
Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining retractor which is a self-locking device used to hold the edges of a wound open during neurosurgery.
Quantity: 65
Why Was This Recalled?
As a result of complaint investigations it was identified that there is a potential that the Leyla Ball Joint Clamp (R2383) may not provide the level of stability needed to maintain retraction in all cases.
Where Was This Sold?
This product was distributed to 22 states: AZ, CA, FL, GA, IL, IN, KY, MA, MI, MS, NE, NM, NY, OH, PA, TN, TX, UT, VA, WA, WV, WI
About Integra Limited
Integra Limited has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report