DePuy Synthes ATTUNE Revision Hinge Femoral Component Recall
DePuy Synthes is recalling 3 units of ATTUNE Revision Hinge Femoral Left Size 4 Cement prosthetic components because external sterile packaging was found adhered to internal packaging, potentially compromising sterility.
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: This is an FDA Class II recall. The source text states only a potential compromise to sterility with no reported illnesses, injuries, or adverse events. The hazard is theoretical rather than realized, placing this in the Moderate category.
Plain-English summary
DePuy (Ireland) is recalling the ATTUNE Revision Hinge Femoral LT SZ 4 CEM prosthetic component (Part Number 150450104, Lot 1007844) distributed nationwide in Minnesota, North Carolina, and Texas. The external sterile packaging was found adhered to the internal sterile packaging, which could have compromised the product's sterility.
Patients or healthcare providers who have this component should contact DePuy to determine appropriate next steps, as use of a non-sterile prosthetic implant could pose a risk to patient safety.
The recalled product
- Product
- Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.
- Manufacturer
- DEPUY (IRELAND)
- Affected units
- 3
Distribution
Part of a larger recall action
This product is one of 9 recalled by DEPUY (IRELAND) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
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