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U.S. Department of Health and Human Services

Class 2 Device Recall Stylus Brand Angled Knives

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  Class 2 Device Recall Stylus Brand Angled Knives see related information
Date Initiated by Firm March 03, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on September 10, 2004
Recall Number Z-0950-04
Recall Event ID 28948
510(K)Number K822112  
Product Classification Knife, Ophthalmic - Product Code HNN
Product Stylus Brand Angled Knives - 52-2912, Slit Knife, parallel sides, bevel up, angled, full handle, 3.0mm
52-3212, Slit Knife, parallel sides, bevel up, angled, full handle, 3.2mm

Code Information Model No. Lot # Exp. date 52-2912 M314590 5/2008 52-3212 M359090 7/2008 
Recalling Firm/
Surgical Specialties Puerto Rico, Inc.
Road 115 Km.12.9
Rincon PR 00677
For Additional Information Contact Judith A. Bradley
800-523-3332 Ext. 2218
Manufacturer Reason
for Recall
Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.
FDA Determined
Cause 2
Action Customers were notified by e-mail and fax of the recall during the period of March 3, 2004 to April 1, 2004. Customers were requested to return the product to Surgical Specialties Corporation, Reading, PA 19606.
Distribution Distribution was nationwide and internationally
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.
510(K) Database 510(K)s with Product Code = HNN and Original Applicant = SHARPOINT, INC.