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.
Reported: January 27, 2021 Initiated: June 6, 2019 #Z-0866-2021
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Skeletal Kinetics, Llc
- Units Affected
- 2 units
- Distribution
- U.S. Nationwide distribution including in the states of TX, NY, FL and AZ.
- Location
- Addison, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Skeletal Kinetics, Llc. Units affected: 2 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 27, 2021. Severity: Moderate. Recall number: Z-0866-2021.
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