Recall Z-2050-2023— Exactech, Inc.
Class II · Ongoing
Class II FDA medical device recall by Exactech, Inc., initiated 2023-06-05. It names 2 FDA 510(k) clearances: K213546, K173372. Product: Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.. Reason: The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction..
- Recalling firm
- Exactech, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-06-05
- Firm location
- Gainesville, FL, United States
510(k) clearances named in this recall
2 on FDA's record- K213546 — ExactechGPS Total Shoulder Application, Equinoxe Planning Software
- K173372 — ExactechGPS Total Shoulder Application
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
Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.
Reason for recall
The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
Data sourced from openFDA. This site is unofficial and independent of the FDA.