Z-0946-04

Stylus Angled Knife - 56-5361, Pilot Tip Knife, bevel up, angled, full handled, 3.2mm and 56-5161, Pilot Tip...

Name: Z-0946-04 Stylus Angled Knife - 56-5361, Pilot Tip Knife, bevel up, angled, full handled, 3.2mm and 56-5161, Pilot Tip...
Creator: Surgical Specialties Puerto Rico, Inc.
Published: 2004-03-03
License: https://open.fda.gov/license/

Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. / initiated 2004-03-03 / Terminated / root cause: packaging

FDA source

Surgical Specialties Puerto Rico, Inc. began a recall of 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 on 2004-03-03. The reason FDA records is "Incorrect placement of the blade in the foam of product results in blade poking through packaging. Compromised sterility and injury to healthcare worker". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0946-04
Status: Terminated
Initiated: 2004-03-03
Posted: 2004-07-20
Terminated: 2004-09-10
Recalling firm: Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
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
Product code: HNN Knife, Ophthalmic
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.
Root cause tag: packaging
FDA root cause: Other
Action: 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.
Distribution: Distribution was nationwide and internationally
Product codes and lots: 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

Product code HNN

K822112Class IOphthalmic KnifeSharpoint, Inc. / cleared 1982-08-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)