Skeletal Kinetics Recalls Osteovation EX Bone Void Filler Kits
Skeletal Kinetics is recalling Osteovation EX 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 (nonunion, lack of bone formation) without reporting specific injuries or fatalities, 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 62 units of Osteovation EX, 3CC, Impact Formula bone void filler kits. The product is indicated to fill bony voids or gaps in the skeletal system, such as those in the extremities, spine, or pelvis. The recall covers specific lot numbers: 17051907, 17102713, 1126984, 1156491, and 1136327.
The recall was initiated because the bone void filler kits may not maintain their setting characteristics for the labeled shelf-life duration. If used, this defect may increase the required surgical and anesthesia time for the patient. Potential longer-term health consequences include incomplete bone formation, lack of bone formation, delayed union, or nonunion.
The affected products were distributed worldwide, including nationwide in the United States and in Australia, Canada, South Africa, and Switzerland. Healthcare providers and patients should stop using the affected lots and contact Skeletal Kinetics for instructions on return or replacement.
The recalled product
- Product
- 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 c
- Manufacturer
- Skeletal Kinetics, Llc
- Affected units
- 62
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 (5)
- Lot Numbers: 17051907
- 17102713
- 1126984
- 1156491
- 1136327.
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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