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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-0947-04
Recall Event ID 28948
510(K)Number K822112  
Product Classification Knife, Ophthalmic - Product Code HNN
Product Stylus Brand Angled Knife - 52-2661, Slit Knife, bevel up, angled full handled, 2.65mm
52-2761, Slit Knife, bevel up, angled, full handled, 2.75mm
52-2861, Slit Knife, bevel up, angled, full handled, 2.85mm
52-2961, Slit Knife, bevel up, angled, full handled, 3.0mm
52-3261, Slit Knife, bevel up, angled, full handled, 3.2mm
52-3561, Slit Knife, bevel up, angled, full handled, 3.5mm
52-2662, Slit Knife, bevel up, angled, blade and tip, 3.2mm
52-3262, Slit Knife, bevel up, angled, blade and tip, 3.2mm
Code Information Model No. Lot # Exp.date 52-2661 M309600 5/2008 52-2662 M309610 8/2008 52-2661 M309620 8/2008 52-2661 M309630 8/2008 52-2661 M264510 3/2008 52-2761 M436360 12/2008 52-2761 M309720 9/2008 52-2761 M309730 9/2008 52-2761 M365020 10/2008 52-2761 M365030 11/2008 52-2861 M309770 5/2008 52-2861 M309780 7/2008 52-2861 M430490 12/2008 52-2861 M437160 1/2009 52-2861 M439540 1/2009 52-2861 M309790 8/2008 52-2861 M309810 9/2008 52-2961 M376790 8/2008 52-2961 M309860 6/2008 52-2961 M309870 7/2008 52-2961 M416990 10/2008 52-3261 M440600 2/2009 52-3261 M262580 3/2008 52-3261 M309940 7/2008 52-3261 M309960 8/2008 52-3261 M309970 8/2008 52-3561 M311070 4/2008 52-2662 M445610 2/2009 52-3262 M280120 3/2008      
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 2		 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.
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