Skeletal Kinetics Recalls Osteovation Impact Bone Void Filler Kits
Skeletal Kinetics is recalling Osteovation Impact bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or 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, delayed union) where specific injury reports are not explicitly stated in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Skeletal Kinetics, LLC is recalling Osteovation Impact 10CC and Osteovation, 10CC, Impact Formula bone void filler kits. The recall involves 661 units distributed worldwide, including the United States and countries such as Australia, Canada, South Africa, and Switzerland. The affected lots are 17051914, 17060506, 1127991, 1128827, 1132180, 1132479, 1134902, and 1142212.
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, 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 and patients should contact Skeletal Kinetics for further instructions regarding the return or replacement of the product.
The recalled product
- Product
- OSTEOVATION IMPACT 10CC and OSTEOVATION, 10CC, IMPACT FORMULA, Product Number: 390-2110, UDI: 813845020092 - 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 de
- Manufacturer
- Skeletal Kinetics, Llc
- Affected units
- 661
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 (8)
- Lot Number: 17051914
- 17060506
- 1127991
- 1128827
- 1132180
- 1132479
- 1134902
- 1142212.
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.
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