The Recall Desk

Manufacturer

Skeletal Kinetics, Llc

49 recalls in our database name Skeletal Kinetics, Llc as the manufacturing or recalling firm.

What the numbers show

Total
49
Critical
0
Severe
9
Most recent
2021-01-27

Of the 49 recalls from Skeletal Kinetics, Llc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (18%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–49 of 49

  • HighFDA (Devices)·Z-2630-2020·2020-07-22

    Skeletal Kinetics Recalls SKAFFOLD RENU FLOW Bone Void Filler Kits

    Skeletal Kinetics is recalling SKAFFOLD RENU FLOW bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.

    Product
    SKAFFOLD RENU FLOW, 10CC. Product Number: SKMA-FL10, UDI: 813845020856 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2616-2020·2020-07-22

    Skeletal Kinetics Recalls Osteovation RMX Bone Void Filler Kits

    Skeletal Kinetics is recalling Osteovation RMX bone void filler kits because they may not maintain setting characteristics for the labeled shelf life, potentially increasing surgical time or causing bone formation issues.

    Product
    OSTEOVATION RMX 5CC. Product Number: 390-6001, UDI: 813845021082 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2600-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt Flow Bone Void Filler Kits

    Skeletal Kinetics is recalling 70 units of Craniosculpt Flow bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.

    Product
    CRANIOSCULPT FLOW, 3CC. Product Number: C-FLOW3CC, UDI: 813845020320 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2593-2020·2020-07-22

    Skeletal Kinetics Recalls Acumed Callos Bone Void Filler Kits

    Skeletal Kinetics is recalling Acumed Callos bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.

    Product
    ACUMED CALLOS INJECT 3CC. Product Number: 65-0003-S, UDI: 813845020221 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2603-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt Flow Bone Void Filler Kits

    Skeletal Kinetics is recalling Craniosculpt Flow bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.

    Product
    CRANIOSCULPT FLOW, OUS, 10CC. Product Number: C-FLOW10CC-OUS, UDI: 813845020382 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2614-2020·2020-07-22

    Skeletal Kinetics Recalls Osteovation Impact Bone Void Filler Kits

    Skeletal Kinetics is recalling Osteovation Impact bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing incomplete bone formation.

    Product
    OSTEOVATION IMPACT 10CC and OSTEOVATION, 10CC, IMPACT FORMULA, Product Number: 390-2110, UDI: 813845020092 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2607-2020·2020-07-22

    Exactech Ossilix Fil Bone Void Filler Recalled for Setting Defects

    Skeletal Kinetics is recalling Exactech Ossilix Fil bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.

    Product
    EXACTECH OSSILIX FIL (MX), 5CC. Product Number: 660-02-05, UDI: 813845021006 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2627-2020·2020-07-22

    Skeletal Kinetics Recalls Skaflow Flow Bone Void Filler Kits

    Skeletal Kinetics is recalling Skaflow Flow bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.

    Product
    SKAFFOLD FLOW, 3CC and SKAFFOLD FLOW (MX) 3CC. Product Number: SKMX-FL03, UDI: 813845020887 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2623-2020·2020-07-22

    Skeletal Kinetics Recalls Osteovationex Bone Void Filler Kits

    Skeletal Kinetics is recalling Osteovationex bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.

    Product
    OSTEOVATIONEX, INJECT 3CC. Product Number: 390-0003, UDI: 813845020016 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2617-2020·2020-07-22

    Skeletal Kinetics Recalls Osteovation Bone Void Filler Kits

    Skeletal Kinetics is recalling Osteovation bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing bone formation issues.

    Product
    OSTEOVATION, 10CC, INJECT FORMULA. Product Number: 390-2010, UDI: 813845020061 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2608-2020·2020-07-22

    Skeletal Kinetics Recalls Ossilix Form Bone Void Filler Kits

    Skeletal Kinetics is recalling 20 units of Ossilix Form bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.

    Product
    EXACTECH OSSILIX FORM (MX), 10CC. Product Number: 660-01-10, UDI: 813845021037 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2633-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt Bone Void Filler Kits

    Skeletal Kinetics is recalling 27 units of Craniosculpt bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.

    Product
    CRANIOSCULPT, CMF IMPACT, 3CC Product Number: C-CMF3CC, UDI: 813845020931 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2606-2020·2020-07-22

    Skeletal Kinetics Recalls Ossilix Fil Bone Void Filler Kits

    Skeletal Kinetics is recalling Ossilix Fil bone void filler kits because they may not maintain setting characteristics for the labeled shelf life, potentially increasing surgical time or causing bone formation issues.

    Product
    EXACTECH OSSILIX FIL (MX), 10CC. Product Number: 660-02-10, UDI: 813845021013 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2609-2020·2020-07-22

    Skeletal Kinetics Recalls Ossilix Form Bone Void Filler Kits

    Skeletal Kinetics is recalling 15 units of Ossilix Form bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.

    Product
    EXACTECH OSSILIX FORM (MX), 5CC. Product Number: 660-01-05, UDI: 813845021020 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2597-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt C Bone Void Filler Kits

    Skeletal Kinetics is recalling Craniosculpt C bone void filler kits because they may not maintain setting characteristics for the labeled shelf life, potentially increasing surgical time or causing bone formation issues.

    Product
    CRANIOSCULPT C, 10CC. Product Number: C-C10CC, UDI: 813845021129 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2625-2020·2020-07-22

    Skeletal Kinetics Recalls SKAFFOLD CMF Impress Bone Void Filler Kits

    Skeletal Kinetics is recalling 12 units of SKAFFOLD CMF Impress bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.

    Product
    SKAFFOLD CMF IMPRESS (MP), 10CC. Product Number: CMMP-IM10, UDI: 813845020696 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2636-2020·2020-07-22

    Skeletal Kinetics Recalls Ossilix Bone Void Filler Kits Due to Setting Defects

    Skeletal Kinetics is recalling 60 units of Ossilix MP Fil bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.

    Product
    EXACTECH OSSILIX MP FIL, 10CC. Product Number: 662-02-10, UDI: 813845021051 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2619-2020·2020-07-22

    Skeletal Kinetics Recalls Osteovation Bone Void Filler Kits

    Skeletal Kinetics is recalling Osteovation bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing bone formation issues.

    Product
    OSTEOVATION, 5CC, IMPACT FORMULA. Product Number: 390-2105, UDI: 813845020085 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2626-2020·2020-07-22

    Skeletal Kinetics Recalls SKAFFOLD CMF Impress Bone Void Filler Kits

    Skeletal Kinetics is recalling SKAFFOLD CMF Impress bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.

    Product
    SKAFFOLD CMF IMPRESS (MP), 5CC. Product Number: CMMP-IM05, UDI: 813845020689 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2628-2020·2020-07-22

    Skeletal Kinetics Recalls SKAFFOLD FLOW Bone Void Filler Kits

    Skeletal Kinetics is recalling SKAFFOLD FLOW bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing incomplete bone formation.

    Product
    SKAFFOLD FLOW (MX) 5CC. Product Number: SKMX-FL05, UDI: 813845020894 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2629-2020·2020-07-22

    Skeletal Kinetics Recalls SKAFFOLD FLOW Bone Void Filler Kits

    Skeletal Kinetics is recalling SKAFFOLD FLOW bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing bone formation issues.

    Product
    SKAFFOLD FLOW, 10CC. Product Number: SKMX-FL10, UDI: 813845020900 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2634-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt Bone Void Filler Kits

    Skeletal Kinetics is recalling Craniosculpt bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.

    Product
    CRANIOSCULPT, CMF IMPACT, 5CC, Product Number: C-CMF5CC, UDI: 813845020948 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2054-2020·2020-05-27

    Skeletal Kinetics Recalls Cranio/Sculpt C Bone Void Filler Due to Sterilization Concerns

    Skeletal Kinetics is recalling 125 units of Cranio/Sculpt C bone void filler because one unit may have been mispackaged and not sterilized.

    Product
    Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranial bone defects and craniotomy cuts with a surface area no larger…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2209-2015·2015-08-05

    Skeletal Kinetics Recalls InjectionPlasty 1.0 Bone Void Filler Kits

    Skeletal Kinetics is recalling 67 kits of InjectionPlasty 1.0 Bone Void Filler due to reports of venous uptake, DVT, and pulmonary embolism in implanted patients.

    Product
    InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calcium phosphate bone void filler. Sterilized using irradiation. The single-use InjectionPlasty 1.0 Kit contains the necessary components for mixing and delivery of the bone void filler. The InjectionPlasty…
    Category
    Medical Device
    Distribution
    1 state