Z-0918-03

2.75 mm Slit Knife, Angled, Bevel Up. Labeled '' Stylus * 2.75 mm Slit Knife Angled, Bevel, Up*One Unit...

Name: Z-0918-03 2.75 mm Slit Knife, Angled, Bevel Up. Labeled '' Stylus *** 2.75 mm Slit Knife Angled, Bevel, Up***One Unit...
Creator: Surgical Specialties Puerto Rico, Inc.
Published: 2003-05-07
License: https://open.fda.gov/license/

Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. / initiated 2003-05-07 / Terminated / root cause: manufacturing process

FDA source

Surgical Specialties Puerto Rico, Inc. began a recall of 2.75 mm Slit Knife, Angled, Bevel Up. Labeled '' Stylus *** 2.75 mm Slit Knife Angled, Bevel, Up***One Unit STERILE R Disposable***Surgical Specialties... on 2003-05-07. The reason FDA records is "Incorrect handle was used in the manufacture of product 52-2761". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0918-03
Status: Terminated
Initiated: 2003-05-07
Posted: 2003-06-05
Terminated: 2004-02-09
Recalling firm: Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
Product: 2.75 mm Slit Knife, Angled, Bevel Up. Labeled '' Stylus *** 2.75 mm Slit Knife Angled, Bevel, Up***One Unit STERILE R Disposable***Surgical Specialties Corporation***Reading, PA 19606***''
Product code: HNN Knife, Ophthalmic
Reason for recall: Incorrect handle was used in the manufacture of product 52-2761
Root cause tag: manufacturing process
FDA root cause: Other
Action: On 5/7/03 the cusotmers were notified of the recall via fax.
Quantity in commerce: 3,420 pieces
Distribution: Nationwide and worldwide. Distribution was to two accounts in the USA and four (4) foreign accounts.
Product codes and lots: Model number: 52-2761 Lot/Serial # Exp. Date M262530 2/2008 M262540 3/2008 M262550 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)