Skeletal Kinetics Recalls Osteovation Bone Void Filler Kits
Skeletal Kinetics is recalling Osteovation bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing bone formation issues.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes potential significant health consequences such as nonunion and delayed union, but does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Skeletal Kinetics, LLC is recalling Osteovation, 5CC, Impact Formula bone void filler kits. The product is indicated to fill bony voids or gaps of the skeletal system, such as those in the extremities, spine, or pelvis. The recall involves 1,393 units distributed worldwide, including in the United States and countries such as Australia, Canada, South Africa, and Switzerland.
The recall was initiated because the bone void filler kits may not maintain their setting characteristics for the labeled shelf-life duration. If the product does not set properly, its use may increase the required surgical and anesthesia time for the patient. Additionally, longer-term health consequences could include incomplete bone formation, lack of bone formation, delayed union, or nonunion.
Healthcare providers and patients who have used or have these specific lots of Osteovation bone void filler kits should contact Skeletal Kinetics, LLC for further instructions. The affected lot numbers are 17040533, 17051911, 17060509, 17102710, 1126986, 1128789, 1134232, 1136330, 1144043, and 1142210.
The recalled product
- Product
- OSTEOVATION, 5CC, IMPACT FORMULA. Product Number: 390-2105, UDI: 813845020085 - 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 crea
- Manufacturer
- Skeletal Kinetics, Llc
- Affected units
- 1,393
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Lot Numbers: 17040533
- 17051911
- 17060509
- 17102710
- 1126986
- 1128789
- 1134232
- 1136330
- 1144043
- 1142210.
Distribution
Part of a larger recall action
This product is one of 45 recalled by Skeletal Kinetics, Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 45 products in this recall →Related recalls
Same manufacturer · Skeletal Kinetics, Llc
See all →- ModerateSkeletal Kinetics Recalls OsteoVation Bone Filler Kits Due to Labeling Discrepancy
FDA (Devices) · 2021-01-27
- ModerateSkeletal Kinetics Recalls OsteoVation Bone Filler Kits Due to Labeling Discrepancy
FDA (Devices) · 2021-01-27
- HighSkeletal Kinetics Recalls Ossilix Form Bone Void Filler Kits
FDA (Devices) · 2020-07-22
- HighSkeletal Kinetics Recalls Craniosculpt Flow Bone Void Filler Kits
FDA (Devices) · 2020-07-22
- HighSkeletal Kinetics Recalls Craniosculpt Bone Void Filler Kits
FDA (Devices) · 2020-07-22
Same hazard · product defect
See all →- SevereShilpa Medicare Recalls Discolored Pemetrexed Injection Vials
FDA (Drugs) · 2026-08-26
- ModerateShilpa Medicare Recalls Discolored PEMRYDI RTU Injection Vials
FDA (Drugs) · 2026-08-26
- ModerateMedline Sterile Water and Saline Bottles Recalled for Leaking Peel-Foil Seals
FDA (Devices) · 2025-05-07
- HighCELL-DYN Ruby hematology analyzer system expiration date validation
FDA (Devices) · 2025-04-30
- HighMedline Procedure Kits with Defective Plastic Syringes Recalled for Safety
FDA (Devices) · 2025-04-02