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U.S. Department of Health and Human Services

Class 2 Device Recall Stylus Brand Slit Knife

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  Class 2 Device Recall Stylus Brand Slit Knife see related information
Date Initiated by Firm May 07, 2003
Date Posted June 05, 2003
Recall Status1 Terminated 3 on February 09, 2004
Recall Number Z-0918-03
Recall Event ID 26317
510(K)Number K822112  
Product Classification Knife, Ophthalmic - Product Code HNN
Product 2.75 mm Slit Knife, Angled, Bevel Up. Labeled '' Stylus *** 2.75 mm Slit Knife Angled, Bevel, Up***One Unit STERILE R Disposable***Surgical Specialties Corporation***Reading, PA 19606***''
Code Information Model number: 52-2761  Lot/Serial # Exp. Date M262530 2/2008 M262540 3/2008 M262550 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 handle was used in the manufacture of product 52-2761
FDA Determined
Cause 2
Other
Action On 5/7/03 the cusotmers were notified of the recall via fax.
Quantity in Commerce 3,420 pieces
Distribution Nationwide and worldwide. Distribution was to two accounts in the USA and four (4) foreign accounts.
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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