Recall Z-2048-2017— Orthosoft, Inc. dba Zimmer CAS

Name: FDA recall Z-2048-2017
Creator: U.S. Food and Drug Administration
Published: 2009-06-09

Class II · Terminated

Class II FDA medical device recall by Orthosoft, Inc. dba Zimmer CAS, initiated 2009-06-09, terminated 2017-05-09. It names one FDA 510(k) clearance: K071929. Product: NDI P7 Position Sensor, Stereotaxic Instrument. Reason: Zimmer CAS voluntarily conducted a retrospective recall on specific P7 Position Sensors (Cameras), installed on Sesamoid and Sesamoid Plasty CAS workstations due to a series of these components determined to be affected with a manufacturing issue whereby they may potentially stop functioning during usage..

Recalling firm: Orthosoft, Inc. dba Zimmer CAS
Classification: Class II
Status: Terminated
Initiated: 2009-06-09
Terminated: 2017-05-09
Firm location: Montreal, N/A, Canada

510(k) clearances named in this recall

1 on FDA's record

K071929 — NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSALOrthosoft, Inc.·cleared 2007-09-19

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

NDI P7 Position Sensor, Stereotaxic Instrument

Reason for recall

Zimmer CAS voluntarily conducted a retrospective recall on specific P7 Position Sensors (Cameras), installed on Sesamoid and Sesamoid Plasty CAS workstations due to a series of these components determined to be affected with a manufacturing issue whereby they may potentially stop functioning during usage.

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