Class 2 Device Recall Stylus Brand Angled Knives

• Date Initiated by Firm: March 03, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on September 10, 2004
• Recall Number: Z-0949-04
• Recall Event ID: 28948
• 510(K)Number: K822112
• Product Classification: Knife, Ophthalmic - Product Code HNN
• Product: Stylus Brand Angled Knife - 54-1010, Sharptome Crescent Knife, bevel up, angled, full handled.; 54-1031, Sharptome Crescent Knife, double bevel, angled, full handled
• Code Information: Model No. Lot # Exp. Date 54-1010 M316220 9/2008 54-1010 M316160 7/2008 54-1010 M316180 7/2008 54-1031 M365220 10/2008
• Recalling Firm/ Manufacturer: 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: Other
• 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.