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

smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.

FDA Recall Z-2242-2021 · Posted None

Recalling FirmSmith & Nephew Orthopaedics Ltd. (Aurora)
Recall StatusTerminated
Product CodeNXT
Date Initiated2021-07-14
Date Terminated2024-05-13
Product Quantity47 units

Reason for Recall

The nail head may become detached during surgery.

Firm Action

The firm notified its consignee by letter on 07/14/2021. The letter explained the issue and the hazard and requested the return of the products.

Root Cause

Component change control

Distribution Pattern

Worldwide distribution - US Nationwide distribution and the countries GB, NO, CA, AU & NZ.

Official Source

View FDA Recall →

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

↑