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

Recall Z-0122-2013 — "**ORTHO SENSOR12-123-A Knee Trial for Trithion1560 Saw grass Corporate Pkwy4Th floorSunrise, FL 33323www.orthosensor.com" Rx Only Sterile/EOMade exclusively for Stryker Orthopaedics. Is the graphic user interface software associated with the graphic user interface,

U.S. FDA — Device Enforcement · United States · 2012-02-04 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0122-2013
Date of alert: 2012-02-04
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Orthosensor
Product category: device
Product type: Devices

Reported risk: Ortho sensor in Sunrise, FL is recalling the Graphics User Interface Software 1.8 (which was updated to version 1.82, validated on 02/13/12). Recall was initiated due to customer feedback which included the line of site between the knee ba lancer and the Link station was obstructed by OR metal stands or trays or the knee balancer device was placed atop of or near the metal stands or trays, interru

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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