Z-2048-2017Class II

NDI P7 Position Sensor, Stereotaxic Instrument

Name: Z-2048-2017 NDI P7 Position Sensor, Stereotaxic Instrument
Creator: Orthosoft, Inc. dba Zimmer CAS
Published: 2009-06-09
License: https://open.fda.gov/license/

Zimmer CAS / initiated 2009-06-09 / Terminated / root cause: manufacturing process

FDA source

Orthosoft, Inc. dba Zimmer CAS began a recall of NDI P7 Position Sensor, Stereotaxic Instrument on 2009-06-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2048-2017
Classification: Class II
Status: Terminated
Initiated: 2009-06-09
Posted: 2017-05-08
Terminated: 2017-05-09
Recalling firm: Zimmer CAS
Product: NDI P7 Position Sensor, Stereotaxic Instrument
Product code: HAW Neurological 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Zimmer CAS sent an Field Recall Notice dated June 9, 2009. Zimmer CAS conducted a retrospective recall/Field Correction on given P7 Position Sensors (Cameras). These were installed on given Sesamoid and Sesamoid Plasty CAS workstations. A series of these components have been determined to be affected with a manufacturing issue whereby they may potentially stop functioning during usage. The failure mode consists in the camera stopping to track and interrupting the application with an error code 0X00000020 being displayed on the navigation panel. For any questions or concerns please contact the Zimmer CAS customer service, 1-866-336-7846.
Quantity in commerce: 34
Distribution: Worldwide Distribution - US Distribution to the states of : KS, MS, WI, NJ, KS, IN, LA, FL and WA., and to the countries of : Canada, Australia, Singapore, Netherlands, UK, Austria, Germany, Switzerland and Czech Republic.
Product codes and lots: Part Number: NDI P7 Position Sensor Product Number 201.053 (a component of part number 521.035, Sesamoid Plasty Camera Arm Kit) Lot/Serial Number: 38 units affected: P7-00321, P7-00339, P7-00360, P7-00361, P7-00362, P7-00363, P7-00364, P7-00365, P7-00366, P7-00368, P7-00369, P7-00370, P7-00371, P7-00372, P7-00373, P7-00375, P7-00387, P7-00412, P7-00414, P7-00415, P7-00416, P7-00417, P7-00418, P7-00419, P7-00420, P7-00421, P7-00422, P7-00423, P7-00431, P7-00451, P7-00452, P7-00453, P7-00562, P7-00563, P7-00565, P7-00568, P7-00569, P7-00590 (The lot number and the serial number are the same)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2048-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2048-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-17	2017-05-08

Product code HAW

K071929Class IINavitrack System- Partial Hip Resurfacing UniversalOrthosoft, Inc. / cleared 2007-09-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)