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U.S. Department of Health and Human Services

Class 2 Device Recall SHARPOINT IQ Geometry Slit Knives

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  Class 2 Device Recall SHARPOINT IQ Geometry Slit Knives see related information
Date Initiated by Firm August 15, 2012
Date Posted November 05, 2012
Recall Status1 Terminated 3 on January 13, 2014
Recall Number Z-0203-2013
Recall Event ID 62945
Product Classification Blade, scalpel - Product Code GES
Product "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3040***"

Ophthalmic surgery
Code Information MABQ150, MAGS310, MAJC690
Recalling Firm/
Manufacturer		 Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
Rd 459 Km 0.6
Montana Industrial Park
Aguadilla PR 00605
For Additional Information Contact Marcia Caro
787-658-1800 Ext. 1808
Manufacturer Reason
for Recall		 Potential for bent tips.
FDA Determined
Cause 2		 Process control
Action 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.
Quantity in Commerce 117,948 units (total)
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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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