Reported Jan 27, 2021 · Terminated
OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturing lot 1130303) - Product Usage: The…
Skeletal Kinetics, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Skeletal Kinetics, Llc · 3885 Arapaho Rd · Addison, TX · 75001-4314
Is this the product you have?
- OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturing
- lot 1130303) - Product UsageThe product provides a bone void filler that is replaced by bone during the healing process
- Lot codes and dates
OsteoVationInject10cc (part number 390-2010manufacturing lot 1130303label no 12464)
- UDI (2)(01) 0 0813845 02006 1 (17) 210501 (10) 1130303
- Amount recalled
- 49 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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