Medtronic Bone Void Filler Recalled for Potential Setting Defects
Medtronic is recalling 36 units of Bone Void Filler, Small, because the product may not maintain its setting characteristics for the labeled shelf-life, potentially increasing surgical time.
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 possible longer-term health consequences such as nonunion or delayed union, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling 36 units of Medtronic Bone Void Filler, Small. The product is an injectable, moldable, and biocompatible calcium phosphate bone void filler used in surgical procedures. The recall was initiated because the product may not maintain its setting characteristics for the labeled shelf-life duration.
The defect may lead to a longer time for the product to set at the time of implantation, which may increase the required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates an incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
The affected product is identified by Product number C07A, GTIN 00813845020504, and Lot Number 1127301. The 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 regarding the return or replacement of the product.
The recalled product
- Product
- Medtronic Bone Void Filler, Small - 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
- 36
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: C07A
- GTIN: 00813845020504
- Lot Number: 1127301
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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