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U.S. Department of Health and Human Services

Class 3 Device Recall Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled

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 Class 3 Device Recall Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angledsee related information
Date Initiated by FirmAugust 21, 2003
Date PostedOctober 15, 2003
Recall Status1 Terminated 3 on January 13, 2004
Recall NumberZ-0026-04
Recall Event ID 27154
510(K)NumberK822112 
Product Classification Knife, Ophthalmic - Product Code HNN
ProductSharpoint 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
For Additional Information ContactJudith A. Bradley
800-523-3332 Ext. 2218
Manufacturer Reason
for Recall
text on product handle is incorrect
FDA Determined
Cause 2
Other
ActionThe consignees were notified via fax on 8/21/03. One customer received a recall letter via mail on 8/22/03.
Quantity in Commerce666 units
DistributionThe 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 CycleTPLC 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) Database510(K)s with Product Code = HNN
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