Exactech Ossilix Fil Bone Void Filler Recalled for Setting Defects
Skeletal Kinetics is recalling Exactech Ossilix Fil 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, and the source text describes potential significant health consequences such as nonunion and delayed union, but does not report specific injuries or hospitalizations.
Plain-English summary
Skeletal Kinetics, LLC is recalling Exactech Ossilix Fil (MX), 5CC bone void filler kits. The recall involves 217 units distributed worldwide, including in the United States and several international countries. The specific lot numbers affected are 17081103, 17092102, 17101915, 1127908, 1132493, 1135468, 1135945, 1139362, and 1144457.
The recall was initiated because the bone void filler kits may not maintain their setting characteristics for the labeled shelf-life duration. This defect could increase the required surgical and anesthesia time for patients. Potential longer-term health consequences include incomplete bone formation, lack of bone formation, delayed union, or nonunion.
Patients who have received this product should contact their healthcare provider for further evaluation and management. The product is indicated to fill bony voids or gaps in the skeletal system, such as those in the extremities, spine, or pelvis.
The recalled product
- Product
- EXACTECH OSSILIX FIL (MX), 5CC. Product Number: 660-02-05, UDI: 813845021006 - 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
- 217
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 (9)
- Lot Numbers: 17081103
- 17092102
- 17101915
- 1127908
- 1132493
- 1135468
- 1135945
- 1139362
- 1144457.
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.
See all 45 products in this recall →Related recalls
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Same hazard · setting defect
See all →- HighSkeletal Kinetics Recalls Ossilix Bone Void Filler Kits Due to Setting Defects
FDA (Devices) · 2020-07-22
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