FDA Enforcement
Class II
Terminated
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3240***" Ophthalmic surgery
Recall: Z-0204-2013
·
Reported November 14, 2012
Enforcement
- Recall Number
- Z-0204-2013
- Event ID
- 62945
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 14, 2012
- Initiation Date
- August 15, 2012
- Classification Date
- November 5, 2012
- Termination Date
- January 13, 2014
- Address
- Rd 459 Km 0.6, Montana Industrial Park, Aguadilla, PR, 00605, United States
Description
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3240***" Ophthalmic surgery
Reason
Potential for bent tips.
Code Info
MAKR840, MALZ570, MALZ580, MAMQ990, MAMR000, MANP250, MAPR320, MAQD910
Distribution
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
Quantity
117,948 units (total)