Recall Z-1029-2015— Orthosensor, Inc.

Name: FDA recall Z-1029-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-05

Class II · Terminated

Class II FDA medical device recall by Orthosensor, Inc., initiated 2014-12-05, terminated 2015-03-13. It names one FDA 510(k) clearance: K130380. Product: Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.. Reason: Presence of one inoperable (dead) sensor pad..

Recalling firm: Orthosensor, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-12-05
Terminated: 2015-03-13
Firm location: Sunrise, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K130380 — ORTHOSENSOR KNEE BALANCEROrthosensor, Inc.·cleared 2013-06-13

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

Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.

Reason for recall

Presence of one inoperable (dead) sensor pad.

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