Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2048-2017 — NDI P7 Position Sensor, Stereotaxic Instrument

U.S. FDA — Device Enforcement · Canada · 2009-06-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2048-2017
Date of alert
2009-06-09
Country / jurisdiction
Canada
Risk level
Class II
Risk type
recall
Brand
Orthosoft, Inc. dba Zimmer CAS
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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