Z-0202-2013 Class II Terminated

Recalled by Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. — Aguadilla, PR

Recall Details

Product Type
Devices
Report Date
November 14, 2012
Initiation Date
August 15, 2012
Termination Date
January 13, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
117,948 units (total)

Product Description

"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2840***" Ophthalmic surgery

Reason for Recall

Potential for bent tips.

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

Code Information

M342500, M342510, M415840, M439130, M446040, M495130, M495160, M510810, M553460, M553470, M553480, M585640, M585740, M652760, M652770, M652780, MADP160, MADP170