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.
Other recalls by Cryolife
- BioGlue Surgical Adhesive, Model BG3510-5-G
FDA Device · Class II · 2021-12-22 · Cryolife - CryoPatch SG Pulmonary Human Cardiac Patch
FDA Device · Class II · 2020-12-30 · Cryolife - CryoValve SG Pulmonary Human Heart Valve
FDA Device · Class II · 2020-12-30 · Cryolife - CryoPatch SG Pulmonary Hemi-Artery Patch
FDA Device · Class II · 2019-05-01 · Cryolife - On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the replacement of diseas…
FDA Device · Class II · 2019-04-03 · Cryolife
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2715-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.