| Class 2 Device Recall NDI P7 Position Sensor, Stereotaxic Instrument | |
Date Initiated by Firm | June 09, 2009 |
Date Posted | May 08, 2017 |
Recall Status1 |
Terminated 3 on May 09, 2017 |
Recall Number | Z-2048-2017 |
Recall Event ID |
75615 |
510(K)Number | K071929 |
Product Classification |
Neurological stereotaxic Instrument - Product Code HAW
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Product | NDI P7 Position Sensor, Stereotaxic Instrument |
Code Information |
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) |
Recalling Firm/ Manufacturer |
Orthosoft, Inc. dba Zimmer CAS 75 Queen St #3300 Montreal Canada
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For Additional Information Contact | Kevin Escapule 574-372-4487 |
Manufacturer 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. |
FDA Determined Cause 2 | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = HAW
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