Recall Z-2715-2017 ยท LWQ Heart-Valve, Mechanical
CryoLife, Inc.
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
| Date | Jun 12, 2015 |
| Status | Terminated |
| Reason | Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring instead of an Anatomic Sewing Ring. |
| 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.