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

The UNI-CP System; Model Number: 330230SND.

FDA Recall Z-1410-2017 · Posted None

Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeJDR
Date Initiated2017-01-25
Date Terminated2017-11-08
Product Quantity39 units

Reason for Recall

The firm received one complaint from one non-US sales representative (France) that the label on the UNI-CP plate was incorrect.

Firm Action

Integra LifeSciences Corp. issued a recall letter/return response form on 1/25/2017.

Root Cause

Device Design

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011716THE UNI-CLIP STAPLENew Deal, S.A. · 2001-08-30

Official Source

View FDA Recall →

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

↑