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

Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514

FDA Recall Z-0568-2020 · Posted None

Recalling FirmWright Medical Technology, Inc.
Recall StatusTerminated
Product CodeGFF
Date Initiated2016-11-08
Date Terminated2020-11-03
Product Quantity66 units

Reason for Recall

The firm discovered a lack of adequate documentation confirming sterility on certain products.

Firm Action

The firm initiated the recall on 11/08/2016 by letter and email to the user level. The firm requested the return of the units.

Root Cause

Process control

Distribution Pattern

US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain

Official Source

View FDA Recall →

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

↑