Z-2715-2017 Class II Terminated
FDA device recall Z-2715-2017 was initiated by CryoLife, Inc. on June 12, 2015 and is designated Class II. 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. The recall status is terminated (terminated August 4, 2020). Affected quantity: 52.
Recall Details
- Product Type
- Devices
- Report Date
- July 19, 2017
- Initiation Date
- June 12, 2015
- Termination Date
- August 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 52
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.
Distribution Pattern
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
Code Information
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