Skeletal Kinetics Recalls Ossilix Bone Void Filler Kits Due to Setting Defects
Skeletal Kinetics is recalling 60 units of Ossilix MP Fil bone void filler kits because they may not maintain 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 potential for significant injury (nonunion, delayed union) but no reported illnesses or injuries are stated in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Skeletal Kinetics, LLC is recalling 60 units of EXACTECH OSSILIX MP FIL, 10CC bone void filler kits. The affected product is indicated to fill bony voids or gaps in the skeletal system, including extremities, spine, and pelvis. The recall involves specific lot numbers 17081106 and 17120617.
The recall was initiated because the bone void filler kits may not maintain their setting characteristics for the labeled shelf-life duration. If used, this defect 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.
The product was distributed worldwide, including nationwide in the United States and in Australia, Canada, South Africa, and Switzerland. Healthcare providers and patients who have used or may have used this product should contact their healthcare provider for guidance.
The recalled product
- Product
- EXACTECH OSSILIX MP FIL, 10CC. Product Number: 662-02-10, UDI: 813845021051 - 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 create
- Manufacturer
- Skeletal Kinetics, Llc
- Affected units
- 60
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 (2)
- Lot Number: 17081106
- 17120617.
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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