Skeletal Kinetics Recalls Ossilix Form Bone Void Filler Kits
Skeletal Kinetics is recalling 20 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 involves a medical device with potential for significant health consequences, including nonunion and delayed bone formation, but the source text does not report any specific illnesses or injuries, 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 20 units of EXACTECH OSSILIX FORM (MX), 10CC bone void filler kits. The affected products are identified by Lot Numbers 1128831 and 1144046. The recall covers units distributed worldwide, including in the United States and in Australia, Canada, South Africa, and Switzerland.
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 of the skeletal system, such as those in the extremities, spine, or pelvis.
Use of the affected products may increase the required surgical and anesthesia time for the patient. Possible longer-term health consequences could include incomplete bone formation, lack of bone formation, delayed union, or nonunion. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- EXACTECH OSSILIX FORM (MX), 10CC. Product Number: 660-01-10, UDI: 813845021037 - 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 cre
- Manufacturer
- Skeletal Kinetics, Llc
- Affected units
- 20
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 Numbers: 1128831
- 1144046.
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
Same manufacturer · Skeletal Kinetics, Llc
See all →- ModerateSkeletal Kinetics Recalls OsteoVation Bone Filler Kits Due to Labeling Discrepancy
FDA (Devices) · 2021-01-27
- ModerateSkeletal Kinetics Recalls OsteoVation Bone Filler Kits Due to Labeling Discrepancy
FDA (Devices) · 2021-01-27
- HighSkeletal Kinetics Recalls Acumed Callos Bone Void Filler Kits
FDA (Devices) · 2020-07-22
- HighSkeletal Kinetics Recalls Craniosculpt Bone Void Filler Kits
FDA (Devices) · 2020-07-22
- HighSkeletal Kinetics Recalls Acumed Callos Bone Void Filler Kits
FDA (Devices) · 2020-07-22
Same hazard · incomplete bone formation
See all →- SevereSkeletal Kinetics Recalls SKAFFOLD RENU FLOW Bone Void Filler Kits
FDA (Devices) · 2020-07-22
- HighSkeletal Kinetics Recalls Ossilix Fil Bone Void Filler Kits
FDA (Devices) · 2020-07-22
- SevereSkeletal Kinetics Recalls Osteovation EX Bone Void Filler Kits
FDA (Devices) · 2020-07-22
- HighSkeletal Kinetics Recalls SKAFFOLD FLOW Bone Void Filler Kits
FDA (Devices) · 2020-07-22
- HighSkeletal Kinetics Recalls Craniosculpt C Bone Void Filler Kits
FDA (Devices) · 2020-07-22