Recall Z-2051-2023— Exactech, Inc.
Class II · Ongoing
Class II FDA medical device recall by Exactech, Inc., initiated 2023-06-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Exactech Ergo Impactor Handle, Catalog #321-09-05.. 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
Product description
Exactech Ergo Impactor Handle, Catalog #321-09-05.
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.