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Recall Observatory FDA recall evidence

Device product

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

Z-0203-2013

August 15, 2012

Class II

Product summary

Firm
Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
Event
Event 62945
Status
Terminated
Classification
Class II
Quantity
117,948 units (total)
Official record key
device-enforcement:Z-0203-2013

Official wording

Reason: Potential for bent tips.

Code information: MABQ150, MAGS310, MAJC690

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for bent tips.