Skeletal Kinetics Recalls Acumed Callos Bone Void Filler Kits
Skeletal Kinetics is recalling Acumed Callos bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing bone formation issues.
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 describes potential risk-of-harm consequences (incomplete bone formation, nonunion) without reporting specific 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 Acumed Callos Inject 10CC bone void filler kits. The product is indicated to fill bony voids or gaps in the skeletal system, including extremities, spine, and pelvis. The recall involves 379 units distributed worldwide, including in the United States and countries such as Australia, Canada, South Africa, and Switzerland.
The recall is due to a defect where 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.
Healthcare providers and patients who have used or have these products in inventory should contact Skeletal Kinetics for further instructions. The affected lot numbers are 17092807, 17101601, 17102508, 17110324, 1126149, 1132567, 1135953, 1137074, and 1140039.
The recalled product
- Product
- ACUMED CALLOS INJECT 10CC. Product Number: 65-0010-S, UDI: 813845020245 - 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 created fr
- Manufacturer
- Skeletal Kinetics, Llc
- Affected units
- 379
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: 17092807
- 17101601
- 17102508
- 17110324
- 1126149
- 1132567
- 1135953
- 1137074
- 1140039.
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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