Product Safety Recalls

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Skeletal Kinetics, Llc Recall 85133

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.

Skeletal Kinetics, Llc Recall 85133 Information

StatusCompleted
Mandated?Voluntary: Firm initiated
Recall NumberZ-0866-2021
Event ID85133
Event DescriptionOsteoVation, 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.
Product TypeDevices
DistributionU.S. Nationwide distribution including in the states of TX, NY, FL and AZ.
Quantity2 units
Recall ReasonA 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.
Device Classification20210127
Device Code InfoOsteoVation, Inject, 5cc (part number 390-2005, manufacturing lot number 1129957, label no. 12464) . UDI: (01) 0 0813845 02005 4 (17) 210401 (10) 1129957
Center Classification Date20210115
Recall Initiation Date20190606
Recalling FirmSkeletal Kinetics, Llc
Initial Notification Letter
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