FDA Device recall Z-2715-2017
On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart…
- FDA Device
- Class II
- terminated
- Published 2017-07-19
On 2017-07-19 the FDA classified a Class II recall of On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart… by Cryolife, citing incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring instead of an Anatomic Sewing Ring.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2715-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-12 |
| Published | 2017-07-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cryolife |
| Distribution | US |
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.
Identifiers
| code_info | Serial #'s: 4622210, 4587605, 4741470, 4750714, 4622025, 4737722, 4737726, 4632012, 4237725, 4616112, 4520208, 4520709,…Serial #'s: 4622210, 4587605, 4741470, 4750714, 4622025, 4737722, 4737726, 4632012, 4237725, 4616112, 4520208, 4520709, 4632013, 4771217, 4771005, 4781414, 4782107, 4782132, 4765118, 4750707, 4508717, 4525417, 4520719, 4771302, 4771302, 4771210, 4751315, 4741406, 4616313, 4781416, 4771305, 4737922, 4520711, 4508804, 4508807, 4712108, 4765119, 4765106, 4587712, 4525415, 4622315, 4622126, 4771205, 4001123, 4771202, 4780914, 4741412, 4717904, 4671765, 458719, 4622225, and 4731908 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2715-2017%22
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