Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Stylus Brand Angled Knives - 52-2912, Slit Knife, parallel sides, bevel up, angled, full handle, 3.0mm 52-3212, Slit Knife, parallel sides, bevel up, angled, full handle, 3.2mm

FDA Recall Z-0950-04 · Posted 2004-07-20

Recalling FirmSurgical Specialties Puerto Rico, Inc.
Recall StatusTerminated
Product CodeHNN
Date Initiated2004-03-03
Date Terminated2004-09-10

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Distribution was nationwide and internationally

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K822112OPHTHALMIC KNIFESharpoint, Inc. · 1982-08-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑