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

Brand name: Stylus 2-0 Polyviolene Double Armed with T Taper needles. Common name: 20- Polyviolene (white braided coated polyester) with T Taper needles (double armed)

FDA Recall Z-0936-04 · Posted 2004-07-20

Recalling FirmSurgical Specialties Corp
Recall StatusTerminated
Product CodeGAT
Date Initiated2003-08-25
Date Terminated2004-08-19
Product Quantity2 boxes

Reason for Recall

sterilization method incorrect

Firm Action

The only customer was notified via email on 8/26/03 that the product was subject to a recall and needed to be returned.

Root Cause

Other

Distribution Pattern

The product was shipped to a wholesaler in Japan.

Official Source

View FDA Recall →

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

↑