Skeletal Kinetics Recalls Acumed Impact Bone Void Filler Kits
Skeletal Kinetics is recalling 40 Acumed Impact 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, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Skeletal Kinetics, LLC is recalling 40 units of Acumed Impact 10CC bone void filler kits. The affected product is indicated to fill bony voids or gaps in the skeletal system, including extremities, spine, and pelvis. The recall covers specific lot numbers: 1126151, 1128829, 1129911, and 1132480.
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 distributed worldwide, including in the United States and in Australia, Canada, South Africa, and Switzerland.
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 should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- ACUMED IMPACT 10CC. Product Number: 65-0110-S, UDI: 813845020269 - 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 from traumatic injury to
- Manufacturer
- Skeletal Kinetics, Llc
- Affected units
- 40
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 (4)
- Lot Numbers: 1126151
- 1128829
- 1129911
- 1132480.
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 Ossilix Form Bone Void Filler Kits
FDA (Devices) · 2020-07-22
- HighSkeletal Kinetics Recalls Craniosculpt Flow Bone Void Filler Kits
FDA (Devices) · 2020-07-22
- HighSkeletal Kinetics Recalls Craniosculpt Bone Void Filler Kits
FDA (Devices) · 2020-07-22
Same hazard · product defect
See all →- SevereShilpa Medicare Recalls Discolored Pemetrexed Injection Vials
FDA (Drugs) · 2026-08-26
- ModerateShilpa Medicare Recalls Discolored PEMRYDI RTU Injection Vials
FDA (Drugs) · 2026-08-26
- ModerateMedline Sterile Water and Saline Bottles Recalled for Leaking Peel-Foil Seals
FDA (Devices) · 2025-05-07
- HighCELL-DYN Ruby hematology analyzer system expiration date validation
FDA (Devices) · 2025-04-30
- HighMedline Procedure Kits with Defective Plastic Syringes Recalled for Safety
FDA (Devices) · 2025-04-02