Recall Z-0083-2019— Orthosensor, Inc.

Name: FDA recall Z-0083-2019
Creator: U.S. Food and Drug Administration
Published: 2018-07-12

Class II · Terminated

Class II FDA medical device recall by Orthosensor, Inc., initiated 2018-07-12, terminated 2019-06-27. It names one FDA 510(k) clearance: K180459. Product: OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R.. Reason: Some sensors were reported to have fluid inside the posterior lateral corner post-surgery..

Recalling firm: Orthosensor, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-07-12
Terminated: 2019-06-27
Firm location: Dania, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K180459 — VERASENSE for Zimmer Biomet PersonaOrthosensor, Inc.·cleared 2018-06-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R.

Reason for recall

Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.

Data sourced from openFDA. This site is unofficial and independent of the FDA.