Agency classClass IIOur severity:Severe FDA (Devices)·Z-2611-2020·Announced 2020-07-22

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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…
Manufacturer: Skeletal Kinetics, Llc
Category: Medical Device — Orthopedic
Hazard: product-failure
surgical-complication
bone-formation-failure
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

Distributed nationwide across the United States.

The notice also names 14 states specifically:

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 →

Same manufacturer · Skeletal Kinetics, Llc

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Same hazard · product failure