DePuy Orthopaedics Recalls Partially Agglomerated SMARTSET GHV Bone Cement
DePuy Orthopaedics is recalling one lot of SMARTSET GHV Gentamicin Bone Cement because it is partially agglomerated, which may cause surgical delays.
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, and the hazard is a manufacturing defect (agglomeration) causing operational delays rather than direct physical injury or illness, fitting the Moderate criteria for low-risk issues.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling one lot of SMARTSET GHV Gentamicin Bone Cement. The product is a self-curing, radiopaque, polymethyl methacrylate-based cement containing antibiotic, used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures.
The recall is due to the cement being partially agglomerated. This condition may result in surgical delays while a replacement package of cement is retrieved and mixed.
The affected product is identified by Cat. No. 545035500 and Lot No. 7915797. A total of 1,267 units were distributed nationwide, including to facilities in California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Mississippi, Montana, North Carolina, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, and West Virginia.
The recalled product
- Product
- SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties…
- Manufacturer
- DePuy Orthopaedics, Inc.
- Affected units
- 1,267
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 (2)
- Cat. No. 545035500
- Lot No. 7915797
Distribution
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