"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3040***" Ophthalmic surgery
Recall
- Recall Number
- Z-0203-2013
- Event Number
- 62945
- Firm
- Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. Rd
- FEI Number
- 3008845715
- Product Code
- GES
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- August 15, 2012
- Posted
- November 5, 2012
- Terminated
- January 13, 2014
- Address
- 459 Km 0.6 Montana Industrial Park, Aguadilla, PR, 00605
Description
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3040***" Ophthalmic surgery
Potential for bent tips.
Angiotech sent an Urgent Product Recall Notification letter dated August 15, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the current inventory, segregate the affected lot numbers, and to return the identified product. Customers were asked to complete the attached Customer Acknowledgement Form and fax to the Quality Assurance department at 787-658-1073. If product was further distributed customers should notify their customers to whom they sold the affected product. Customers with questions should call 787-658-1800 option 2 ext. 1775 or 787-658-1800 option 2 ext 1807. For questions regarding this recall call 787-658-1800.
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
117,948 units (total)