• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 3 Device Recall Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled see related information
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
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
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

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.
-
-