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

Auto SutureTA 45 Reloadable Stapler,Single Patient Use, 4.8mm DST Series Ref: TA4548S

FDA Recall Z-0962-04 · Posted 2004-07-20

Recalling FirmUnited States Surgical
Recall StatusTerminated
Product CodeGDW
Date Initiated2004-05-05
Date Terminated2006-11-15

Reason for Recall

Stapler may clamp without the staples being fired into the tissue

Firm Action

United States Surgical notiied direct accounts by letter dated 5/5/04. Accounts are requested to inventory and quarantine product for return to USS.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013860AUTO SUTURE SURGICAL STAPLESUnited States Surgical, A Division of Tyco Healthc · 2001-12-19

Official Source

View FDA Recall →

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

↑