DePuy SmartSet GMV Endurance Gentamicin Bone Cement Recalled for Uncleared Indications
DePuy Orthopaedics is recalling SmartSet GMV Endurance Gentamicin Bone Cement because it is intended for uses not cleared by the FDA.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is regulatory (uncleared indications) rather than a direct physical defect causing harm, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 16,040 units of SmartSet GMV Endurance Gentamicin Bone Cement (REF 3105-040). The product is a sterile, self-curing, radiopaque, polymethyl methacrylate-based cement containing the antibiotic gentamicin. It is used to secure metal or polymer prostheses to living bone during arthroplasty procedures where infection by gentamicin-sensitive organisms is a potential risk.
The recall was initiated because the product is intended for use in indications that have not been cleared by the US FDA. The Instructions for Use (IFU) state the product is for the fixation of prostheses to living bone in arthroplasty procedures of joints in which infection by gentamicin-sensitive organisms is a potential risk.
The affected units were distributed in Puerto Rico and the US Virgin Islands. Specific lot numbers are listed in the official recall record. Healthcare providers and patients should contact DePuy Orthopaedics for further instructions regarding the return or replacement of the product.
The recalled product
- Product
- SmartSet¿ Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or…
- Manufacturer
- DePuy Orthopaedics, Inc.
- Affected units
- 16,040
Distribution
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