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

2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the Vantage Total Ankle System - Product Usage: To assist the surgeon in the implantation of Vantage Total Ankle System components according to a conventional technique for total ankle replacement. These instruments are single-use, provided sterile, and intended for transient use.

FDA Recall Z-0361-2020 · Posted None

Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeNDL
Date Initiated2019-10-02
Date Terminated2023-05-19
Product Quantity9 units

Reason for Recall

Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended.

Firm Action

Exactech notified customers on about 10/02/2019, via "URGENT MEDICAL DEVICE RECALL" letter. Customers were informed that the 2.4mm x 2.5" Fluted Pin Pouch was found to contain a single pin rather than four (4) as labeled. Instructions included to immediately cease distribution or use of the affected product, provide the information to customers if further distributed, identify and quarantine any of the affected devices in inventory, and complete and return the provided Recall Acknowledgement Form and Recall Inventory Response Form to Exactech via email to [email protected].

Root Cause

Error in labeling

Distribution Pattern

US Nationwide distribution in the states of GA, NY, OH, VA.

Official Source

View FDA Recall →

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

↑