Skeletal Kinetics Recalls Cranio/Sculpt C Bone Void Filler Due to Sterilization Concerns
Skeletal Kinetics is recalling 125 units of Cranio/Sculpt C bone void filler because one unit may have been mispackaged and not sterilized.
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 potential sterilization failure, which poses a risk of harm (infection) even though no injuries have been reported yet, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Skeletal Kinetics, LLC is recalling 125 units of Cranio/Sculpt C, 10cc, Bone Void Filler (Lot 1129289). The recall was initiated due to a potential product mix-up where one unit of OsteoVation EX, 3cc, which may not have been sterilized, was inadvertently packaged as Cranio/Sculpt C, 10cc.
The affected product is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranial bone defects, and craniotomy cuts. The recall covers units distributed nationwide in the state of Florida.
Healthcare providers and patients should stop using the affected product and contact Skeletal Kinetics for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- Skeletal Kinetics, Llc
- Hazard
- Affected units
- 125
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 1129289
Distribution
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