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Medtronic Sofamor Danek Usa, Inc - Dallas Distribution

Complete recall history across all FDA and CPSC categories — 3 total recalls

Medtronic Sofamor Danek Usa, Inc - Dallas Distribution 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 (3)

FDA medical device enforcement actions by Medtronic Sofamor Danek Usa, Inc - Dallas Distribution

Date Product Reason Class
May 13, 2016 Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number:... Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm S... Class II
Apr 8, 2016 Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for u... Incorrect color coding and attachment reference were included on the labeling... Class II
Oct 21, 2015 Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used... The wire pass hole is not present on the tools. 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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