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.
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 (incomplete bone formation, nonunion) but no reported 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 442 units of Acumed Callos Inject 5cc bone void filler kits. The product is indicated to fill bony voids or gaps of the skeletal system, including defects in the extremities, spine, and pelvis. The recall covers specific lot numbers distributed worldwide, including in the United States and several international countries.
The recall was initiated because the bone void filler kits may not maintain their setting characteristics for the labeled shelf-life duration. If the product fails to set properly, it may increase the required surgical and anesthesia time for the patient. 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 guidance. The recall affects specific lot numbers listed in the official FDA notice.
The recalled product
- Product
- ACUMED CALLOS INJECT 5CC. Product Number: 65-0005-S, UDI: 813845020238 - 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 fro
- Manufacturer
- Skeletal Kinetics, Llc
- Affected units
- 442
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 (11)
- Lot Numbers: 17091301
- 17080401
- 17092101
- 17101914
- 17110326
- 1127621
- 1129605
- 1132312
- 1132624
- 1135465
- 1135954.
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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