The Recall Desk

FDA (Devices) recall action 85529

Osteomed, LLC recalled 12 products on 2020-06-10

The FDA (Devices) publishes a recall like this one as 12 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 12 pages.

Products
12
Announced
2020-06-10
Critical
0
Units
6,350

Why these products were recalled

Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–12 of 12

  • ModerateFDA (Devices)··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
    Distribution
    46 states
  • ModerateFDA (Devices)··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
    Distribution
    46 states
  • ModerateFDA (Devices)··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
    Distribution
    46 states
  • ModerateFDA (Devices)··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
    Distribution
    46 states
  • ModerateFDA (Devices)··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
    Distribution
    46 states
  • ModerateFDA (Devices)··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
    Distribution
    46 states
  • ModerateFDA (Devices)··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
    Distribution
    46 states
  • ModerateFDA (Devices)··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
    Distribution
    46 states
  • ModerateFDA (Devices)··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
    Distribution
    46 states
  • ModerateFDA (Devices)··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
    Distribution
    46 states
  • ModerateFDA (Devices)··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
    Distribution
    46 states
  • ModerateFDA (Devices)··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
    Distribution
    46 states