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.

Open, Classified

Equinoxe Humeral Stem, Primary, Press Fit, 11mm

FDA Recall Z-0884-2021 · Posted None

Recalling FirmExactech, Inc.
Recall StatusOpen, Classified
Product CodeHSD
Date Initiated2020-11-09
Product Quantity14 devices

Reason for Recall

Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.

Firm Action

Exactech distributed the recall notice titled, "URGENT PRODUCT RECALL NOTICE" to consignees in possession of affected inventory in the US and Australia on November 9, 2020 via email. In order to comply with the notice, consignees have been instructed to: " Immediately cease distribution or use of this product. " Extend the information to their accounts that may have this product in their possession. " Identify and quarantine any of the subject devices in their inventory. " Complete and return the attached Recall Inventory Response Form to Exactech.

Root Cause

Employee error

Distribution Pattern

Distributed within the US to KS, OH, CA. International distribution to Australia and Germany.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042021EXACTECH EQUINOXE SHOULDER SYSTEMExactech, Inc. · 2004-10-26

Official Source

View FDA Recall →

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

↑