Nuvasive Specialized Orthopedics Inc
Complete recall history across all FDA and CPSC categories — 7 total recalls
Nuvasive Specialized Orthopedics 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 (7)
FDA medical device enforcement actions by Nuvasive Specialized Orthopedics Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| Feb 12, 2021 | NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System ... | Due to not having the full complement of biological assessments for all poten... | Class II |
| Feb 12, 2021 | Precice Bone Transport - Product Usage: intended for limb lengthening, open... | Due to complaints of adverse events potentially related to biological safety.... | Class II |
| Feb 12, 2021 | NUVASIVE FREEDOM: End Cap for PRECICE Intramedullary Limb Lengthening Syst... | Due to not having the full complement of biological assessments for all poten... | Class II |
| Feb 12, 2021 | NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail Sys... | Due to not having the full complement of biological assessments for all poten... | Class II |
| Feb 12, 2021 | PRECICE STRYDE - Product Usage: intended for limb lengthening, open and clo... | Due to complaints of adverse events potentially related to biological safety.... | Class II |
| Feb 12, 2021 | PRECICE PLATE - Product Usage: intended for limb lengthening, open and clos... | Due to complaints of adverse events potentially related to biological safety.... | Class II |
| Jul 24, 2020 | NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur... | During explantation, standard removal tools can generate sufficient forces to... | 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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