FDA-Device2013-09-04Class II
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.
Integra Limited
Hazard
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.
Sold states
Worldwide Distribution - USA including Puerto Rico and the states of AZ, CA, FL, GA, IL, IN, KY, MA, MI, MS, NE, NM, NY, OH, PA, TN, TX, UT, VA, WA, WI and WV., and the countries of Spain, Singapore, South Africa, Canada, Libya,Pakistan and Cayman Islands.
Affected count
65
Manufactured in
311 Enterprise Dr, Plainsboro, NJ, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2056-2013Don't want to check this manually?
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