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U.S. Department of Health and Human Services

Class 2 Device Recall Stylus Brand Angled Knives

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 Class 2 Device Recall Stylus Brand Angled Knivessee related information
Date Initiated by FirmMarch 03, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on September 10, 2004
Recall NumberZ-0946-04
Recall Event ID 28948
510(K)NumberK822112 
Product Classification Knife, Ophthalmic - Product Code HNN
ProductStylus Angled Knife - 56-5361, Pilot Tip Knife, bevel up, angled, full handled, 3.2mm and 56-5161, Pilot Tip Knife, bevel up, angled, full handled, 5.2mm
Code Information Model No. Lot # Exp. date 56-5361 M262510 5/2008 56-5361 M309090 6/2008 56-5361 M309150 11/2008 56-5361 M439510 1/2009 56-5161 M317030 6/2008   
Recalling Firm/
Manufacturer		 Surgical Specialties Puerto Rico, Inc.
Road 115 Km.12.9
Rincon PR 00677
For Additional Information ContactJudith A. Bradley
800-523-3332 Ext. 2218
Manufacturer Reason
for Recall		Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.
FDA Determined
Cause 2		Other
ActionCustomers were notified by e-mail and fax of the recall during the period of March 3, 2004 to April 1, 2004. Customers were requested to return the product to Surgical Specialties Corporation, Reading, PA 19606.
DistributionDistribution was nationwide and internationally
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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