CLASS II Device recall · Reported 22 Jul 2020 · FDA Enforcement Report
Osteovation Ex, 3cc, Impact Formula recalled by Skeletal Kinetics
Skeletal Kinetics is recalling Osteovation Ex, 3cc, Impact Formula, distributed nationwide in the US. The recall was initiated on 6 Apr 2020 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-2612-2020
- FDA event ID
- 85517
- Recalling firm
- Skeletal Kinetics, Addison, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Apr 2020
- FDA classified
- 15 Jul 2020
- Reported
- 22 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Spinal Implants
Timeline
| 6 Apr 2020 | Recall initiated by company | |
| 15 Jul 2020 | Classified by FDA | +100 days |
| 22 Jul 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
OSTEOVATION EX, 3CC, IMPACT FORMULA. Product Number: 390-0203, UDI: 813845020030 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
Where it was distributed
Worldwide distribution - US Nationwide distribution including in the states of AL, CA, CO, FL, IL, MO, MS, OH, OK, OR, TN, TX, WI and the countries of Australia, Canada, South Africa, Switzerland.
Nationwide AlabamaCaliforniaColoradoFloridaIllinoisMissouriMississippiOhioOklahomaOregonTennesseeTexasWisconsin
Questions about this recall
Why was it recalled?
Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
Which lots are affected?
Lot Numbers: 17051907, 17102713, 1126984, 1156491, 1136327.
Where was it sold?
Worldwide distribution - US Nationwide distribution including in the states of AL, CA, CO, FL, IL, MO, MS, OH, OK, OR, TN, TX, WI and the countries of Australia, Canada, South Africa, Switzerland.
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
44 other products · FDA event 85517This product is part of a recall event; the main page for the event is Osteovation Ex, 5cc, Impact Formula recalled by Skeletal Kinetics.
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 | OsteoVation, Inject Bone Filler Kits, 5cc 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 |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |