Date Initiated by Firm | August 21, 2003 |
Date Posted | October 15, 2003 |
Recall Status1 |
Terminated 3 on January 13, 2004 |
Recall Number | Z-0026-04 |
Recall Event ID |
27154 |
510(K)Number | K822112 |
Product Classification |
Knife, Ophthalmic - Product Code HNN
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Product | Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives. |
Code Information |
M190500 exp 11/2007 and M203840 exp 12/2007 |
Recalling Firm/ Manufacturer |
Surgical Specialties Corp 100 Dennis Drive Reading PA 19606-3776
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For Additional Information Contact | Judith A. Bradley 800-523-3332 Ext. 2218 |
Manufacturer Reason for Recall | text on product handle is incorrect |
FDA Determined Cause 2 | Other |
Action | The consignees were notified via fax on 8/21/03. One customer received a recall letter via mail on 8/22/03. |
Quantity in Commerce | 666 units |
Distribution | The products were shipped to two hospitals in CA, two sales representatives in NC & IL, and three wholesalers in IL, Belgium, Canada, and Austrailia. |
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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