Skeletal Kinetics Recalls Osteovationex Bone Void Filler Kits
Skeletal Kinetics is recalling Osteovationex bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.
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 involves a risk of harm (incomplete bone formation, delayed union) without reported illnesses or injuries, fitting the High severity criteria.
Plain-English summary
Skeletal Kinetics, LLC is recalling 101 units of Osteovationex, Inject 3CC (Product Number: 390-0003, UDI: 813845020016). The product is a bone void filler indicated to fill bony voids or gaps in the skeletal system, such as those in the extremities, spine, or pelvis. The affected lots are 17100402, 1127942, 1130302, 1135740, 1142070, and 1142943.
The recall was initiated because the bone void filler kits may not maintain their setting characteristics for the labeled shelf-life duration. The agency classifies this as a Class II recall. The distribution pattern includes worldwide distribution and US nationwide distribution in specific states, as well as in Australia, Canada, South Africa, and Switzerland.
Use of the affected product may increase the required surgical and anesthesia time for the patient. Possible longer-term health consequences include incomplete bone formation, lack of bone formation, delayed union, or nonunion. Healthcare providers and patients should contact the recalling firm for further instructions regarding the affected units.
The recalled product
- Product
- OSTEOVATIONEX, INJECT 3CC. Product Number: 390-0003, UDI: 813845020016 - 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 fro
- Manufacturer
- Skeletal Kinetics, Llc
- Affected units
- 101
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 (6)
- Lot Numbers: 17100402
- 1127942
- 1130302
- 1135740
- 1142070
- 1142943.
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.
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