Skeletal Kinetics Recalls Osteovationex Bone Void Filler Kits
Skeletal Kinetics is recalling Osteovationex 2cc Inject Formula bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.
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 3/5 (High).
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 risk of harm (incomplete bone formation, delayed union) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Skeletal Kinetics, LLC is recalling 35 units of Osteovationex 2cc Inject Formula (Product Number: 390-0002, UDI: 813845020009). The affected lots are 1127941, 1130301, and 1135741. The product is a bone void filler indicated to fill bony voids or gaps in the skeletal system, such as those in the extremities, spine, or pelvis.
The recall was initiated because the bone void filler kits may not maintain their setting characteristics for the labeled shelf-life duration. The FDA has classified this as a Class II recall. The distribution pattern includes worldwide distribution and US nationwide distribution in specific states, as well as in Australia, Canada, South Africa, and Switzerland.
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 or lack of bone formation, delayed union, or nonunion. Patients who have received this product should contact their healthcare provider for guidance.
The recalled product
- Product
- OSTEOVATIONEX 2CC INJECT FORMULA. Product Number: 390-0002, UDI: 813845020009 - 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
- Affected units
- 35
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)
- Lot Numbers: 1127941
- 1130301
- 1135741.
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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