Recall Z-0308-2021— Exactech, Inc.
Class II · Terminated
Class II FDA medical device recall by Exactech, Inc., initiated 2020-09-25, terminated 2023-05-01. It names 2 FDA 510(k) clearances: K101909, K092900. Product: Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.. Reason: The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem..
- Recalling firm
- Exactech, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-09-25
- Terminated
- 2023-05-01
- Firm location
- Gainesville, FL, United States
510(k) clearances named in this recall
2 on FDA's record- K101909 — EXACTECH EQUINOXE, PLATFORM FRACTURE STEM
- K092900 — EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Equinoxe Platform Fracture Stem, 6.5mm, Right - 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.