Surgical Specialties Puerto Rico, Inc. Road Stylus 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stylus 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
Brand
Surgical Specialties Puerto Rico, Inc. Road
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Surgical Specialties Puerto Rico, Inc. Road is recalling Stylus Angled Knife - 56-5361, Pilot Tip Knife, bevel up, angled, full handled, 3.2mm and 56-5161, P due to Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare wor. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker.
Recommended Action
Per FDA guidance
Customers 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026