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
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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
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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 |
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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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510(K) Database | 510(K)s with Product Code = HNN
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