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Orthosoft, Inc. dba Zimmer CAS

Complete recall history across all FDA and CPSC categories — 7 total recalls

Orthosoft, Inc. dba Zimmer CAS appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (7)

FDA medical device enforcement actions by Orthosoft, Inc. dba Zimmer CAS

Date Product Reason Class
Jan 7, 2022 NavitrackER Kit A: Knee, Model Number 20-8000-000-07, The product was released for distribution without passing sterilization resul... Class II
Feb 20, 2017 SmartTools Knee System Orthopedic Stereotaxic Instrument There has been an increase in the number of complaints regarding bent or brok... Class II
Oct 6, 2011 Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS ... Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack Syst... Class II
Jun 9, 2009 NDI P7 Position Sensor, Stereotaxic Instrument Zimmer CAS voluntarily conducted a retrospective recall on specific P7 Positi... Class II
Oct 28, 2008 Navitrack System - OS Knee Universal, Stereotaxic instrument Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack Syst... Class II
Jun 20, 2008 Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack Syst... Class III
Jun 4, 2008 Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is u... Zimmer CAS voluntarily conducted a retrospective recall of the Sesamoid Plas... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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