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.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall involving a medical device with potential for significant injury (incomplete bone formation, nonunion), which aligns with the 'Severe' criteria for FDA Class II recalls with significant injury reports or risks.
Plain-English summary
Skeletal Kinetics, LLC is recalling 88 units of Osteovation EX, 5CC, Impact Formula bone void filler kits. The affected lots are 1126985, 1128788, 1133246, and 1135313. The product is indicated to fill bony voids or gaps of the skeletal system, including those in the extremities, spine, and pelvis.
The recall was initiated because the bone void filler kits may not maintain their setting characteristics for the labeled shelf-life duration. The FDA has classified this as a Class II recall. Use of the 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.
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 further instructions.
The recalled product
- Product
- OSTEOVATION EX, 5CC, IMPACT FORMULA. Product Number: 390-0205, UDI: 813845020047 - 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
- 88
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 (4)
- Lot Numbers: 1126985
- 1128788
- 1133246
- 1135313.
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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