Recall Z-2715-2017— CryoLife, Inc.
Class II · Terminated
Class II FDA medical device recall by CryoLife, Inc., initiated 2015-06-12, terminated 2020-08-04. FDA's recall record names no specific 510(k) clearance for this event. Product: On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions. Reason: Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring instead of an Anatomic Sewing Ring..
- Recalling firm
- CryoLife, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-12
- Terminated
- 2020-08-04
- Firm location
- Kennesaw, GA, United States
Product description
On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions
Reason for recall
Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring instead of an Anatomic Sewing Ring.
Data sourced from openFDA. This site is unofficial and independent of the FDA.