Skeletal Kinetics, Llc
Complete recall history across all FDA and CPSC categories — 49 total recalls
Skeletal Kinetics, 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 (49)
FDA medical device enforcement actions by Skeletal Kinetics, Llc
| Date | Product | Reason | Class |
|---|---|---|---|
| Apr 6, 2020 | SKAFFOLD RENU FLOW, 5CC. Product Number: SKMA-FL05, UDI: 813845020849 - Prod... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | EXACTECH OSSILIX FORM (MX), 5CC. Product Number: 660-01-05, UDI: 81384502102... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | EXACTECH OSSILIX FORM (MX), 10CC. Product Number: 660-01-10, UDI: 8138450210... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | OSTEOVATION EX, 3CC, IMPACT FORMULA. Product Number: 390-0203, UDI: 81384502... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | ACUMED IMPACT 5CC. Product Number: 65-0105-S, UDI: 813845020252 - Product Us... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | ACUMED IMPACT 10CC. Product Number: 65-0110-S, UDI: 813845020269 - Callos is... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | OSTEOVATION, 5CC, INJECT FORMULA. Product Number: 390-2005, UDI: 81384502005... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | SK SKAFFOLD IMPRESS 10CC. Product Number: SKAF-IM10, UDI: 813845020795 - Pro... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | SKAFFOLD RENU FLOW, 10CC. Product Number: SKMA-FL10, UDI: 813845020856 - Pro... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | OSTEOVATION, 3CC, IMPACT FORMULA. Product Number: 390-2103, UDI: 81384502007... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | CRANIOSCULPT FLOW, 10CC. Product Number: C-FLOW10CC, UDI: 813845020368 - - P... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | OSTEOVATIONEX, INJECT 3CC. Product Number: 390-0003, UDI: 813845020016 - Pro... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | CRANIOSCULPT, FLOW 5CC. Product Number: C-FLOW5CC, UDI: 813845020337 - Produ... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | CRANIOSCULPT, CMF IMPACT, 5CC, Product Number: C-CMF5CC, UDI: 813845020948 -... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | MEDTRONIC BONE VOID FILLER, SMALL. Product Number: C07A, UDI: 813845020504 -... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | CRANIOSCULPT FLOW, OUS, 5CC Product Number: C-FLOW5CC-OUS, UDI: 813845020351... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | CRANIOSCULPT C, 10CC. Product Number: C-C10CC, UDI: 813845021129 - Product U... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | CRANIOSCULPT C, 3CC. Product Number: C-C3CC, UDI: 813845021105 - Product Usa... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | OSTEOVATIONEX 2CC INJECT FORMULA. Product Number: 390-0002, UDI: 81384502000... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | CRANIOSCULPT C, 5CC. Product Number: C-C5CC, UDI: 813845021112 - - Product U... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | OSTEOVATION, 10CC, INJECT FORMULA. Product Number: 390-2010, UDI: 8138450200... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | SKAFFOLD FLOW, 3CC and SKAFFOLD FLOW (MX) 3CC. Product Number: SKMX-FL03, UD... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | SKAFFOLD CMF IMPRESS (MP), 5CC. Product Number: CMMP-IM05, UDI: 813845020689... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | ACUMED CALLOS INJECT 3CC. Product Number: 65-0003-S, UDI: 813845020221 - Pr... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | ACUMED CALLOS INJECT 10CC. Product Number: 65-0010-S, UDI: 813845020245 - Pr... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | OSTEOVATION RMX 5CC. Product Number: 390-6001, UDI: 813845021082 - Product U... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | OSTEOVATION IMPACT 10CC and OSTEOVATION, 10CC, IMPACT FORMULA, Product Number... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | CRANIOSCULPT FLOW, CAN, 10CC, Product Number: C-FLOW10CC-CAN, UDI: 813845020... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | SKAFFOLD FLOW (MX) 5CC. Product Number: SKMX-FL05, UDI: 813845020894 - Produ... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | CRANIOSCULPT FLOW, 3CC. Product Number: C-FLOW3CC, UDI: 813845020320 - - Pro... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | CRANIOSCULPT, CMF IMPACT, 10CC, Product Number: C-CMF10CC, UDI: 813845020955... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | SKAFFOLD FLOW, 10CC. Product Number: SKMX-FL10, UDI: 813845020900 - Product ... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | CRANIOSCULPT, CMF IMPACT, 3CC Product Number: C-CMF3CC, UDI: 813845020931 - ... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | EXACTECH OSSILIX FIL (MX), 5CC. Product Number: 660-02-05, UDI: 813845021006... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | ACUMED CALLOS INJECT 5CC. Product Number: 65-0005-S, UDI: 813845020238 - Pro... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | EXACTECH OSSILIX FIL (MX), 10CC. Product Number: 660-02-10, UDI: 81384502101... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | MEDTRONIC BONE VOID FILLER, LARGE. Product Number: C07B, UDI: 813845020511 -... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | SKAFFOLD CMF IMPRESS (MP), 10CC. Product Number: CMMP-IM10, UDI: 81384502069... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | OSTEOVATION RMX 10CC. Product Number: 390-6002, UDI: 813845021099 - Product ... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | OSTEOVATION, 5CC, IMPACT FORMULA. Product Number: 390-2105, UDI: 81384502008... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | OSTEOVATIONEX 5CC, INJECT FORMULA. Product Number: 390-0005, UDI: 8138450200... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | CRANIOSCULPT FLOW, CAN, 5CC. Product Number: C-FLOW5CC-CAN, UDI: 81384502034... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | CRANIOSCULPT FLOW, OUS, 10CC. Product Number: C-FLOW10CC-OUS, UDI: 813845020... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | EXACTECH OSSILIX MP FIL, 10CC. Product Number: 662-02-10, UDI: 813845021051 ... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 6, 2020 | OSTEOVATION EX, 5CC, IMPACT FORMULA. Product Number: 390-0205, UDI: 81384502... | Bone void filler kits may not maintain its setting characteristics for the la... | Class II |
| Apr 3, 2020 | Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage:... | Potential product mix-up. The recalling firm has determined that one unit of ... | Class II |
| Jun 6, 2019 | OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturi... | A discrepancy was found between the Mixing Instruction Card and the Instructi... | Class II |
| Jun 6, 2019 | OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturin... | A discrepancy was found between the Mixing Instruction Card and the Instructi... | Class II |
| May 29, 2015 | InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calciu... | Reports of venous uptake, DVT, pulmonary embolism in patients who were implan... | 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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