OsteoVation recall
OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturing lot 1130303) - Product Usage: The product provides a bone void filler…
Why was OsteoVation 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
OsteoVation, Inject, 10cc (part number 390-2010, manufacturing lot 1130303, label no 12464). UDI (2): (01) 0 0813845 02006 1 (17) 210501 (10) 1130303
- Product
- OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturing lot 1130303) - Product Usage: The product provides a bone void filler…
- Recalling firm
- Skeletal Kinetics, Llc
- Quantity
- 49 units
- Distribution
- U.S. Nationwide distribution including in the states of TX, NY, FL and AZ.
- Recall date
- January 27, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)