FDA Medical Device Recalls (openFDA)
Orthosoft, Inc. dba Zimmer CAS: NDI P7 Position Sensor, Stereotaxic Instrument
- Recall number
- Z-2048-2017
- Recalling firm
- Orthosoft, Inc. dba Zimmer CAS
- Product
- NDI P7 Position Sensor, Stereotaxic Instrument
- Status
- Terminated
- Initiated
- 2009-06-09
- Posted
- 2017-05-08
- Terminated
- 2017-05-09
- 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.
- 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
- 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.
- Lot, serial or model codes
- 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)
- 510(k) numbers
- ["K071929"]
- PMA numbers
- not on file
- Product code
- HAW
- Firm FEI
- 3003714383
- Firm city
- Montreal
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28