Recall Z-0168-2020— Exactech, Inc.
Class II · Terminated
Class II FDA medical device recall by Exactech, Inc., initiated 2019-09-10, terminated 2023-05-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components according to a conventional technique for total shoulder replacement. The wire is single-use, provided sterile, and intended for transient use.. Reason: Potential for the wire to fracture at the threads and remain in the glenoid..
- Recalling firm
- Exactech, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-09-10
- Terminated
- 2023-05-01
- Firm location
- Gainesville, FL, United States
Product description
Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components according to a conventional technique for total shoulder replacement. The wire is single-use, provided sterile, and intended for transient use.
Reason for recall
Potential for the wire to fracture at the threads and remain in the glenoid.
Data sourced from openFDA. This site is unofficial and independent of the FDA.