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U.S. Department of Health and Human Services

Enforcement Report - Week of November 14, 2012

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Product Detail

Product Description "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2840***" Ophthalmic surgery
Recall Number Z-0202-2013
Classification Class II
Code Info M342500, M342510, M415840, M439130, M446040, M495130, M495160, M510810, M553460, M553470, M553480, M585640, M585740, M652760, M652770, M652780, MADP160, MADP170
Product Distributed Qty 117,948 units (total)
Reason For Recall Potential for bent tips.

Event Detail

Event Id 62945
Product Type Devices
Status Ongoing
Recalling Firm Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
City Aguadilla
State PR
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-15
Initial Firm Notification of Consignee or Public Letter
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