Medtronic Bone Void Filler Kit Recalled for Setting Defects
Medtronic is recalling 41 units of Bone Void Filler Kits because the product may not set properly, potentially increasing surgical time and causing incomplete bone formation.
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 involves a medical device with a risk of harm (incomplete bone formation, increased surgical time) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling 41 units of the Extremities, Large Kit Assy, US, 15/3 (Product number: EL153B; Lot Number: 0009541707). This product is an injectable, moldable, and biocompatible calcium phosphate bone void filler used for implantation.
The recall was initiated because the product may not maintain its setting characteristics for the labeled shelf-life duration. If the device does not set correctly, it may take longer to set during implantation, which could increase the required surgical and anesthesia time for the patient. Additionally, if the device seeps or creeps from its intended position before setting, it may result in incomplete void or gap filling. This could lead to longer-term health consequences, including incomplete bone formation, lack of bone formation, delayed union, or nonunion.
The affected units were distributed nationwide to California, Florida, Illinois, Indiana, Kentucky, Minnesota, Missouri, Montana, Ohio, Pennsylvania, Texas, Virginia, and Washington. Healthcare providers and patients should contact Medtronic for further instructions on how to proceed with the recall.
The recalled product
- Product
- Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Affected units
- 41
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 (3)
- Product number: EL153B
- GTIN: 00643169157248
- Lot Number: 0009541707
Distribution
Part of a larger recall action
This product is one of 3 recalled by Medtronic Sofamor Danek USA Inc 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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