Medtronic Bone Void Filler Recalled for Potential Failure to Set
Skeletal Kinetics is recalling Medtronic Bone Void Filler kits because they may not maintain setting characteristics for the labeled shelf life, potentially increasing surgical time or causing bone formation issues.
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. The hazard involves a medical device that may fail to set, leading to potential surgical complications and bone formation issues, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Skeletal Kinetics, LLC is recalling Medtronic Bone Void Filler, Large (Product Number: C07B, UDI: 813845020511). The recall involves 1,053 units distributed worldwide, including in the United States and in Australia, Canada, South Africa, and Switzerland. Specific lot numbers affected are 17040508, 17091408, 1127302, 1129303, and 1129715.
The recall was initiated because the bone void filler kits may not maintain their setting characteristics for the duration of the labeled shelf life. The product is indicated to fill bony voids or gaps in the skeletal system, such as those in the extremities, spine, or pelvis, which may be surgically created or result from traumatic injury.
Use of the affected 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. Healthcare providers should stop using the affected lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- MEDTRONIC BONE VOID FILLER, LARGE. Product Number: C07B, UDI: 813845020511 - 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
- Affected units
- 1,053
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 (5)
- Lot Numbers: 17040508
- 17091408
- 1127302
- 1129303
- 1129715.
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.
See all 45 products in this recall →Related recalls
Same manufacturer · Skeletal Kinetics, Llc
See all →- ModerateSkeletal Kinetics Recalls OsteoVation Bone Filler Kits Due to Labeling Discrepancy
FDA (Devices) · 2021-01-27
- ModerateSkeletal Kinetics Recalls OsteoVation Bone Filler Kits Due to Labeling Discrepancy
FDA (Devices) · 2021-01-27
- HighSkeletal Kinetics Recalls Ossilix Form Bone Void Filler Kits
FDA (Devices) · 2020-07-22
- HighSkeletal Kinetics Recalls Craniosculpt Flow Bone Void Filler Kits
FDA (Devices) · 2020-07-22
- HighSkeletal Kinetics Recalls Craniosculpt Bone Void Filler Kits
FDA (Devices) · 2020-07-22
Same hazard · device failure
See all →- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
FDA (Devices) · 2026-08-12
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighCOAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12