Z-0307-2021 Class II Terminated
FDA device recall Z-0307-2021 was initiated by Exactech, Inc. on Sep 25, 2020 and is designated Class II. Reason for recall: The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem. The recall status is terminated (terminated May 1, 2023). Affected quantity: 25 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 4, 2020
- Initiation Date
- Sep 25, 2020
- Termination Date
- May 1, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25 devices
Product Description
Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
Reason for Recall
The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of CA, CO, FL, IN, KY, NY, OH, TX, and Puerto Rico. The countries of Australia, Germany, France, Spain, India, Italy, South Korea, Singapore, UK, Luxembourg, and Brazil.
Code Information
Catalog: 304-21-07; Serial Ranges: 4968615-4968627; 4952421-4952432
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0307-2021
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026