Reported May 17, 2017 · Terminated
NDI P7 Position Sensor, Stereotaxic Instrument
Orthosoft, Inc. dba Zimmer CAS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Orthosoft, Inc. dba Zimmer CAS · 75 Queen St #3300 · Montreal, N/A · N/A
Is this the product you have?
- NDI P7 Position Sensor, Stereotaxic Instrument
- Lot codes and dates
- Part NumberNDI P7 Position Sensor Product Number 201.053 (a component of part number 521.035, Sesamoid Plasty
- Camera Arm Kit) Lot/Serial Number38
- units affectedP7-00321, 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)
- Amount recalled
- 34
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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