Skeletal Kinetics Recalls Craniosculpt Bone Void Filler Due to Setting Defects
Skeletal Kinetics is recalling 51 units of Craniosculpt bone void filler because the product may not maintain its 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 a defect that could lead to significant health consequences such as nonunion or delayed union, but the source text does not report any actual 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 51 units of Craniosculpt, CMF Impact, 10CC bone void filler kits. The product is indicated to fill bony voids or gaps in the skeletal system, including the extremities, spine, and pelvis. The recall is limited to Lot Number 17040544.
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. Possible longer-term health consequences include incomplete bone formation, lack of bone formation, delayed union, or nonunion.
The affected units were distributed worldwide, including nationwide in the United States and in Australia, Canada, South Africa, and Switzerland. Healthcare providers and patients should stop using the affected product and contact Skeletal Kinetics for instructions on return or replacement.
The recalled product
- Product
- CRANIOSCULPT, CMF IMPACT, 10CC, Product Number: C-CMF10CC, UDI: 813845020955 - 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 creat
- Manufacturer
- Skeletal Kinetics, Llc
- Affected units
- 51
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 (1)
- Lot Number: 17040544.
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 · 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