Medtronic Bone Void Filler Recalled for Potential Failure to Set Properly
Skeletal Kinetics is recalling Medtronic Bone Void Filler kits that may not maintain setting characteristics, potentially increasing surgical time or causing bone formation issues.
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 agency classified this as an FDA Class II recall. The source text explicitly lists potential serious health consequences, including lack of bone formation and nonunion, which aligns with the rubric criteria for a Severe rating involving significant injury or health risk.
Plain-English summary
Skeletal Kinetics, LLC is recalling Medtronic Bone Void Filler, Small (Product Number: C07A, UDI: 813845020504). The recall involves 491 units distributed worldwide, including in the United States and in Australia, Canada, South Africa, and Switzerland. The affected lot numbers are 17040505, 17091405, 1127301, and 1129236.
The recall was initiated because the bone void filler kits may not maintain their setting characteristics for the labeled shelf-life duration. The product is indicated to fill bony voids or gaps in the skeletal system, such as those in the extremities, spine, or pelvis, and is designed to resorb and be replaced by bone during the healing process.
Use of the affected product may increase the required surgical and anesthesia time for the patient. Possible longer-term health consequences could include incomplete bone formation, lack of bone formation, delayed union, or nonunion. Healthcare providers should stop using the affected lots and contact the recalling firm for further instructions.
The recalled product
- Product
- MEDTRONIC BONE VOID FILLER, SMALL. Product Number: C07A, UDI: 813845020504 - 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
- Manufacturer
- Skeletal Kinetics, Llc
- Category
- Medical Device — Orthopedic
- Affected units
- 491
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: 17040505
- 17091405
- 1127301
- 1129236.
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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