Medtronic Bone Void Filler Recalled for Potential Setting Defects
Medtronic is recalling 6 units of Bone Void Filler, Large, because the product may not maintain its setting characteristics for the labeled shelf-life.
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 defect that could lead to significant health consequences such as nonunion or delayed union, but the source text does not report any actual injuries or illnesses, fitting 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 6 units of Medtronic Bone Void Filler, Large. The product is an injectable, moldable, and biocompatible calcium phosphate bone void filler. The recall is due to a concern that the product may not maintain its setting characteristics for the labeled shelf-life duration.
The affected units have product number C07B, GTIN 00813845020511, and Lot Number 1127302. These units were distributed nationwide to California, Florida, Illinois, Indiana, Kentucky, Minnesota, Missouri, Montana, Ohio, Pennsylvania, Texas, Virginia, and Washington.
Use of the affected product 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 recalled product
- Product
- Medtronic Bone Void Filler, Large - 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
- 6
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: C07B
- GTIN: 00813845020511
- Lot Number: 1127302
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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