Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Sharpoint ClearTrap Trapezoid Clear Corneal/Implant Knife

  • 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 2 Device Recall Sharpoint ClearTrap Trapezoid Clear Corneal/Implant Knifesee related information
Date Initiated by FirmJanuary 07, 2003
Date PostedApril 01, 2003
Recall Status1 Terminated 3 on March 31, 2003
Recall NumberZ-0705-03
Recall Event ID 25816
510(K)NumberK822112 
Product Classification Knife, Ophthalmic - Product Code HNN
ProductSharpoint ClearTrap Trapezoid Clear Corneal/Implant Knife. Ophthalmic Knife 2.5 mm x 3.5 mm.
Code Information Model # 75-2525, Lot #M118200
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		size mislabeled on product handle
FDA Determined
Cause 2		Other
ActionOn 1/7/03, one account was contacted via telephone. On 1/10/03, a recall letter was faxed to that account. On 3/11/03, this wholesale account was asked to contact a hospital sub account that received a direct shipment. The other account was the complainant and telephone communications were occurring.
Quantity in Commerce635 units
DistributionThe product was shipped to 2 wholesale accounts in PA and LA.
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
-
-