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

INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453

FDA Recall Z-0731-2020 · Posted None

Recalling FirmAAP Implantate Ag
Recall StatusTerminated
Product CodeHTW
Date Initiated2019-01-25
Date Terminated2024-09-30
Product Quantity2 units

Reason for Recall

Products were distributed with the incorrect instructions for use.

Firm Action

The firm notified its sole consignee about the labeling issue by email on 01/25/2019 and provided the correct instructions for use.

Root Cause

Other

Distribution Pattern

Texas

Official Source

View FDA Recall →

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

↑