Z-2715-2017Class II

On-X Prosthetic Heart Valve

Name: Z-2715-2017 On-X Prosthetic Heart Valve
Creator: CryoLife, Inc.
Published: 2015-06-12
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2015-06-12 / Terminated / root cause: labeling and UDI

FDA source

CryoLife, Inc. began a recall of On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the... on 2015-06-12. FDA classified it as Class II and gives the reason as "Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring instead of an Anatomic Sewing Ring". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2715-2017
Classification: Class II
Status: Terminated
Initiated: 2015-06-12
Posted: 2017-07-12
Terminated: 2020-08-04
Recalling firm: Artivion, Inc.
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
Product code: LWQ Heart-Valve, Mechanical
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On-X LTI Management Team had assessed this event to not be reportable. Correction were done by the On-X LTI in 2015.
Quantity in commerce: 52
Distribution: Worldwide Distribution - US Nationwide in the states of AL, CA, FL, IA, IN, LA, MA, MN, MO, MS, NC, OR, PA, and TN. and the countries of Finland, United Kingdom and Israel
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2715-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2715-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-11

Product code LWQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)