The Recall Desk

FDA (Devices) recall action 85133

Skeletal Kinetics, Llc recalled 2 products on 2021-01-27

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2021-01-27
Critical
0
Units
51

Why these products were recalled

A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10 cc bone void filler kits. No customer complaints or reports of injury have been received.

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

1–2 of 2

  • ModerateFDA (Devices)··2021-01-27

    Skeletal Kinetics Recalls OsteoVation Bone Filler Kits Due to Labeling Discrepancy

    Skeletal Kinetics is recalling 2 units of OsteoVation Inject Bone Filler Kits because of a discrepancy between the Mixing Instruction Card and the Instructions for Use.

    Product
    OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot number 1129957) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Distribution
    5 states
  • ModerateFDA (Devices)··2021-01-27

    Skeletal Kinetics Recalls OsteoVation Bone Filler Kits Due to Labeling Discrepancy

    Skeletal Kinetics is recalling 49 units of OsteoVation bone filler kits because the mixing instructions on the card do not match the Instructions for Use.

    Product
    OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturing lot 1130303) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Distribution
    5 states