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

EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments.

FDA Recall Z-2945-2020 · Posted None

Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeHRS
Date Initiated2020-08-24
Date Terminated2022-07-11
Product Quantity71 units

Reason for Recall

Multiple or incorrect expiration dates were provided on the affected designation labels.

Firm Action

On August 24th the firm sent via email a notification to affected consignees. Consignees are asked to inspect inventory, locate and quarantine affected devices. Sales Reps and or distributors are instructed to notify customers of the field action and ensure required actions are complete. Affected product will be returned to Smith & Nephew. All consignees are asked to complete a Response Form, even if they do not have product to return.

Root Cause

Error in labeling

Distribution Pattern

International Distribution to the countries of Denmark, Sweden, France and Spain.

Official Source

View FDA Recall →

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

↑