CLASS II Device recall · Reported 27 Jan 2021 · FDA Enforcement Report
OsteoVation, Inject Bone Filler Kits, 5cc recalled by Skeletal Kinetics
Skeletal Kinetics is recalling OsteoVation, Inject Bone Filler Kits, 5cc (, distributed nationwide in the US. The recall was initiated on 6 Jun 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0866-2021
- FDA event ID
- 85133
- Recalling firm
- Skeletal Kinetics, Addison, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Jun 2019
- FDA classified
- 15 Jan 2021
- Reported
- 27 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 6 Jun 2019 | Recall initiated by company | |
| 15 Jan 2021 | Classified by FDA | +589 days |
| 27 Jan 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide distribution including in the states of TX, NY, FL and AZ.
Questions about this recall
Why was it 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 lots are affected?
OsteoVation, Inject, 5cc (part number 390-2005, manufacturing lot number 1129957, label no. 12464) . UDI: (01) 0 0813845 02005 4 (17) 210401 (10) 1129957
Where was it sold?
U.S. Nationwide distribution including in the states of TX, NY, FL and AZ.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 85133| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | OsteoVation, Inject, Bone Filler Kits 10cc recalled by Skeletal Kinetics | Skeletal Kinetics | Other | Nationwide |
More recalls from Skeletal Kinetics
All 49| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | OsteoVation, Inject, Bone Filler Kits 10cc recalled by Skeletal Kinetics | Skeletal Kinetics | Other | Nationwide |
| Device | CLASS II | Skaffold Renu Flow, 5cc recalled by Skeletal Kinetics | Skeletal Kinetics | Device Malfunction | Nationwide |
| Device | CLASS II | Exactech Ossilix Form (mx), 5cc recalled by Skeletal Kinetics | Skeletal Kinetics | Device Malfunction | Nationwide |
| Device | CLASS II | Exactech Ossilix Form (mx), 10cc recalled by Skeletal Kinetics | Skeletal Kinetics | Device Malfunction | Nationwide |
| Device | CLASS II | Osteovation Ex, 3cc, Impact Formula recalled by Skeletal Kinetics | Skeletal Kinetics | Device Malfunction | Nationwide |
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