Ortho Solutions Inc

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

Ortho Solutions Inc 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 Ortho Solutions Inc

Date Product Reason Class
Apr 19, 2017 Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps ar... There is a material mislabeling of the AFN End Cap. Class II
Jul 21, 2016 FPS 35mm x 3.5 mm non-locking screw Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-L... Class II
Jul 14, 2015 Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD... Ortho Solutions Inc is initiating a recall on behalf of UltOS 3.5mm locking s... 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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