Skeletal Kinetics Recalls InjectionPlasty 1.0 Bone Void Filler Kits
Skeletal Kinetics is recalling 67 kits of InjectionPlasty 1.0 Bone Void Filler due to reports of venous uptake, DVT, and pulmonary embolism in implanted patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves reports of serious injuries, specifically deep vein thrombosis (DVT) and pulmonary embolism, which aligns with the rubric criteria for 'Severe' (score 4) involving significant injury reports.
Plain-English summary
Skeletal Kinetics, LLC is recalling 67 kits of InjectionPlasty 1.0 Bone Void Filler. The product is an injectable, biocompatible calcium phosphate bone void filler used to fill bony voids or gaps in the skeletal system. The recall includes specific lot numbers with expiration dates ranging from August 2015 to October 2017.
The recall was initiated following reports of venous uptake, deep vein thrombosis (DVT), and pulmonary embolism in patients who had the device implanted. The affected kits were distributed in the United States, including Puerto Rico.
Healthcare providers and patients should stop using the affected kits and contact Skeletal Kinetics for further instructions. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calcium phosphate bone void filler. Sterilized using irradiation. The single-use InjectionPlasty 1.0 Kit contains the necessary components for mixing and delivery of the bone void filler. The InjectionPlasty…
- Manufacturer
- Skeletal Kinetics, Llc
- Affected units
- 67
Distribution
Distributed in 1 state:
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