Spinal Elements, Inc
Complete recall history across all FDA and CPSC categories — 23 total recalls
Spinal Elements, 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 (23)
FDA medical device enforcement actions by Spinal Elements, Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| Apr 9, 2015 | Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury ... | Some rods may not meet the appropriate traceability requirements including th... | Class III |
| Dec 18, 2014 | Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This de... | Spinal Elements is recalling the Ti-Bond related brochures that includes LT-1... | Class II |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 60mm Straight Rod, Part Number: 60101-060. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a... | Class III |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030.... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a... | Class III |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod, Part Number: 60100-060. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a... | Class III |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod, Part Number: 60100-100. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a... | Class III |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 90 MM Lordosed Rod, Part Number: 60100-090. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a... | Class III |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 120mm Straight Rod, Part Number: 60101-120. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a... | Class III |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 40 MM Lordosed Rod, Part Number: 60100-040.... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a... | Class III |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 100mm Straight Rod, Part Number: 60101-100. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a... | Class III |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 80 MM Lordosed Rod, Part Number: 60100-080. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a... | Class III |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 110mm Lordosed Rod, Part Number: 60100-110. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a... | Class III |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 70mm Straight Rod, Part Number: 60101-070. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a... | Class III |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod, Part Number: 60100-070. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a... | Class III |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 30mm Straight Rod, Part Number: 60101-030. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a... | Class III |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a... | Class III |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a... | Class III |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 50mm Straight Rod, Part Number: 60101-050. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a... | Class III |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number: 60101-090. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a... | Class III |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod, Part Number: 60100-120. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a... | Class III |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a... | Class III |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 50 MM Lordosed Rod, Part Number: 60100-050. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a... | Class III |
| Apr 17, 2009 | Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. ... | Spinal Elements has initiated a recall for the Mercury Spinal System due to a... | Class III |
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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