Osteomed, LLC

Complete recall history across all FDA and CPSC categories — 15 total recalls

Osteomed, LLC 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 (15)

FDA medical device enforcement actions by Osteomed, LLC

Date Product Reason Class
May 31, 2023 REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, St... Screws for osteotomies have contain an undersize screwhead which has the pote... Class II
May 31, 2023 REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile Screws for osteotomies have contain an undersize screwhead which has the pote... Class II
Oct 28, 2021 OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 RE... Due to consoles not in compliance with the latest electrical safety standards... Class II
Apr 2, 2020 OSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - Product U... Incorrect shelf-life for bone void filler kits; the product may not maintain ... Class II
Apr 2, 2020 OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product U... Incorrect shelf-life for bone void filler kits; the product may not maintain ... Class II
Apr 2, 2020 OSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - Product Usa... Incorrect shelf-life for bone void filler kits; the product may not maintain ... Class II
Apr 2, 2020 OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product ... Incorrect shelf-life for bone void filler kits; the product may not maintain ... Class II
Apr 2, 2020 OSTEOVATION RMX 10 CC Injectable. REF/UDI: 390-6002/ /00813845021099 - Produc... Incorrect shelf-life for bone void filler kits; the product may not maintain ... Class II
Apr 2, 2020 OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Produc... Incorrect shelf-life for bone void filler kits; the product may not maintain ... Class II
Apr 2, 2020 OSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Us... Incorrect shelf-life for bone void filler kits; the product may not maintain ... Class II
Apr 2, 2020 OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product U... Incorrect shelf-life for bone void filler kits; the product may not maintain ... Class II
Apr 2, 2020 OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product ... Incorrect shelf-life for bone void filler kits; the product may not maintain ... Class II
Apr 2, 2020 OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Pro... Incorrect shelf-life for bone void filler kits; the product may not maintain ... Class II
Apr 2, 2020 OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usa... Incorrect shelf-life for bone void filler kits; the product may not maintain ... Class II
Apr 2, 2020 OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product ... Incorrect shelf-life for bone void filler kits; the product may not maintain ... 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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