The Recall Desk

Manufacturer

Osteomed, LLC

15 recalls in our database name Osteomed, LLC as the manufacturing or recalling firm.

What the numbers show

Total
15
Critical
0
Severe
1
Most recent
2023-07-19

Of the 15 recalls from Osteomed, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (7%) 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.

1–15 of 15

  • HighFDA (Devices)·Z-2108-2023·2023-07-19

    Osteomed AutoDrive Screws Recalled for Undersized Screw Head

    Osteomed recalls orthopedic AutoDrive screws used in osteotomy procedures due to undersized screw heads that could pass through the mounting plate hole, potentially affecting surgical fixation.

    Product
    REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2107-2023·2023-07-19

    Orthopedic Screw Recall Due to Undersized Head in Surgical Device

    Osteomed is recalling orthopedic screws with undersized heads that may pass through bone plates. Affected lot numbers were distributed nationwide in the US and Singapore.

    Product
    REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0335-2022·2021-12-15

    OsteoMed Surgical Consoles Recalled for Electrical Safety Violations

    OsteoMed OsteoPower Power Consoles and footswitches are being recalled due to non-compliance with electrical safety standard IEC 60601. The product has shocked a patient, creating a significant electrical hazard.

    Product
    OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Conso
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2180-2020·2020-06-10

    Osteomed Recalls Osteovationex Bone Void Filler Due to Shelf-Life Error

    Osteomed, LLC is recalling 70 units of Osteovationex 2cc Inject Formula because the product may not maintain its setting characteristics for the labeled shelf-life duration.

    Product
    OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2191-2020·2020-06-10

    Osteomed Recalls Osteovation RMX Injectable Due to Shelf-Life Labeling Error

    Osteomed, LLC is recalling 651 units of Osteovation RMX 10 CC Injectable bone void filler kits because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.

    Product
    OSTEOVATION RMX 10 CC Injectable. REF/UDI: 390-6002/ /00813845021099 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2186-2020·2020-06-10

    Osteomed Recalls Osteovationex Bone Void Filler Due to Shelf-Life Error

    Osteomed, LLC is recalling 153 units of Osteovationex 3cc ImpactFormula bone void filler because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.

    Product
    OSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2189-2020·2020-06-10

    Osteomed Recalls Osteovation RMX Injectable Bone Void Filler Kits

    Osteomed is recalling 278 units of Osteovation RMX Injectable Bone Void Filler kits due to incorrect shelf-life labeling that may affect product setting characteristics.

    Product
    OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2184-2020·2020-06-10

    Osteomed Recalls Osteovation Bone Void Filler Due to Shelf-Life Error

    Osteomed is recalling 436 units of Osteovation 10cc Inject Formula because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.

    Product
    OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2183-2020·2020-06-10

    Osteomed Recalls Osteovation Bone Void Filler Due to Shelf-Life Error

    Osteomed, LLC is recalling 417 units of Osteovation 5cc Inject Formula because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.

    Product
    OSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2182-2020·2020-06-10

    Osteomed Recalls Osteovationex Bone Void Filler Due to Shelf-Life Error

    Osteomed, LLC is recalling 647 units of Osteovationex 5cc Inject Formula because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.

    Product
    OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2190-2020·2020-06-10

    Osteomed Recalls Osteovation Bone Void Filler Kits Due to Shelf-Life Error

    Osteomed, LLC is recalling Osteovation 10 CC Impact Formula bone void filler kits because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.

    Product
    OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2181-2020·2020-06-10

    Osteomed Recalls Osteovationex Bone Void Filler Due to Shelf-Life Error

    Osteomed, LLC is recalling Osteovationex 3cc Inject Formula bone void fillers because the product may not maintain its setting characteristics for the labeled shelf-life duration.

    Product
    OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2187-2020·2020-06-10

    Osteomed Recalls Osteovation 3CC ImpactFormula Bone Void Filler Kits

    Osteomed is recalling 409 units of Osteovation 3CC ImpactFormula bone void filler kits due to incorrect shelf-life labeling that may affect product setting characteristics.

    Product
    OSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2188-2020·2020-06-10

    Osteomed Recalls Osteovation 5cc Impactformula Bone Void Filler Kits

    Osteomed is recalling Osteovation 5cc Impactformula bone void filler kits because the product may not maintain its setting characteristics for the labeled shelf-life duration.

    Product
    OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2185-2020·2020-06-10

    Osteomed Recalls Osteovationex Bone Void Filler Due to Shelf-Life Error

    Osteomed is recalling 300 units of Osteovationex 5cc ImpactFormula bone void filler kits because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.

    Product
    OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Osteomed

medical device manufacturer

Country
United States
Founded
1990

Official website

Source: Wikidata (Q7107621), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.