Skeletal Kinetics Recalls Ossilix Form Bone Void Filler Kits
Skeletal Kinetics is recalling 15 units of Ossilix Form 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 is classified as FDA Class II, and the source text describes potential significant health consequences such as nonunion and delayed union, but does not report any confirmed injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Skeletal Kinetics, LLC is recalling 15 units of EXACTECH OSSILIX FORM (MX), 5CC bone void filler kits (Product Number: 660-01-05, UDI: 813845021020, Lot Number: 1132473). The product is indicated to fill bony voids or gaps of the skeletal system, including extremities, spine, and pelvis. The recall is due to the possibility that the bone void filler kits may not maintain their setting characteristics for the labeled shelf-life duration.
The affected units were distributed worldwide, including nationwide distribution in the United States (specifically in AL, CA, CO, FL, IL, MO, MS, OH, OK, OR, TN, TX, and WI) and in Australia, Canada, South Africa, and Switzerland. The source text does not specify the exact dates of distribution or the specific facilities where the products were used.
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 on how to proceed with the recall.
The recalled product
- Product
- EXACTECH OSSILIX FORM (MX), 5CC. Product Number: 660-01-05, UDI: 813845021020 - 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 crea
- Manufacturer
- Skeletal Kinetics, Llc
- Affected units
- 15
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 (1)
- Lot Number: 1132473.
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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