Z-0204-2013 Class II Terminated
FDA device recall Z-0204-2013 was initiated by Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. on August 15, 2012 and is designated Class II. Reason for recall: Potential for bent tips. The recall status is terminated (terminated January 13, 2014). Affected quantity: 117,948 units (total).
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 72-3240***" 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
MAKR840, MALZ570, MALZ580, MAMQ990, MAMR000, MANP250, MAPR320, MAQD910