FDA-Device2012-11-14Class II

"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3040***" Ophthalmic surgery

Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
Hazard

Potential for bent tips.

Sold states
Worldwide Distribution - USA including DE,IL, NC, CA, CO, GA, KY, PA, MD, MN, NY, and MA and internationally to Austria, UAE, China, Argentina, Italy, Taiwan, Czech Republic, Australia, UK, India, Germany, Spain, France, South Africa, Malaysia, Japan, Lebanon, Korea, Greece, Saudi Arabia, Switzerland, Pakistan, Tunisia, Serbia, Morocco, Netherlands, Portugal, Truk, Belgium, and New Zealand
Affected count
117,948 units (total)
Manufactured in
Rd 459 Km 0.6, Montana Industrial Park, Aguadilla, PR, United States
Products
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3040***" Ophthalmic surgery

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0203-2013

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