Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cranio/Sculpt C Recalled by Skeletal Kinetics, Llc Due to Potential product mix-up. The recalling firm has determined...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Skeletal Kinetics, Llc directly.
Affected Products
Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranial bone defects and craniotomy cuts with a surface area no larger than 25cm2. CRANIO/SCULPT C may be used in the restoration or augmentation of bony contours of the cranial bone skeleton.
Quantity: 125 units
Why Was This Recalled?
Potential product mix-up. The recalling firm has determined that one unit of OsteoVation EX, 3cc that may not have been sterilized was inadvertently packaged as CranioSculpt C, 10cc.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Skeletal Kinetics, Llc
Skeletal Kinetics, Llc has 49 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report