Z-0947-04

Stylus Brand Angled Knife - 52-2661, Slit Knife, bevel up, angled full handled, 2.65mm 52-2761, Slit Knife...

Name: Z-0947-04 Stylus Brand Angled Knife - 52-2661, Slit Knife, bevel up, angled full handled, 2.65mm 52-2761, Slit Knife...
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 Brand Angled Knife - 52-2661, Slit Knife, bevel up, angled full handled, 2.65mm 52-2761, Slit Knife, bevel up, angled, full handled, 2.75mm 52-2861... 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-0947-04
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 Brand Angled Knife - 52-2661, Slit Knife, bevel up, angled full handled, 2.65mm 52-2761, Slit Knife, bevel up, angled, full handled, 2.75mm 52-2861, Slit Knife, bevel up, angled, full handled, 2.85mm 52-2961, Slit Knife, bevel up, angled, full handled, 3.0mm 52-3261, Slit Knife, bevel up, angled, full handled, 3.2mm 52-3561, Slit Knife, bevel up, angled, full handled, 3.5mm 52-2662, Slit Knife, bevel up, angled, blade and tip, 3.2mm 52-3262, Slit Knife, bevel up, angled, blade and tip, 3.2mm
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 52-2661 M309600 5/2008 52-2662 M309610 8/2008 52-2661 M309620 8/2008 52-2661 M309630 8/2008 52-2661 M264510 3/2008 52-2761 M436360 12/2008 52-2761 M309720 9/2008 52-2761 M309730 9/2008 52-2761 M365020 10/2008 52-2761 M365030 11/2008 52-2861 M309770 5/2008 52-2861 M309780 7/2008 52-2861 M430490 12/2008 52-2861 M437160 1/2009 52-2861 M439540 1/2009 52-2861 M309790 8/2008 52-2861 M309810 9/2008 52-2961 M376790 8/2008 52-2961 M309860 6/2008 52-2961 M309870 7/2008 52-2961 M416990 10/2008 52-3261 M440600 2/2009 52-3261 M262580 3/2008 52-3261 M309940 7/2008 52-3261 M309960 8/2008 52-3261 M309970 8/2008 52-3561 M311070 4/2008 52-2662 M445610 2/2009 52-3262 M280120 3/2008

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)