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 72-2740***" Ophthalmic surgery |
|---|---|
| Recall Number | Z-0201-2013 |
| Classification | Class II |
| Code Info | MAFD350, M381400, M407870, M439070, M439090, M466140, M495140, M495190, M510800, M554700, M554740, M585650, M656720, M656730, MABL380, MABQ000, MADM740 |
| 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 |
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