DeRoyal TOTAL HIP KIT orthopedic prosthetic device recalled
DeRoyal Industries Inc voluntarily recalled 45 units of the DeRoyal TOTAL HIP KIT (Lot 57686947, expiration 5/1/2025), distributed across 23 US states. The FDA classified this as a Class II recall, initiated November 3, 2022.
What this means for you
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: FDA Class II classification indicates potential health risk, but no illnesses or injuries have been reported. The voluntary, firm-initiated nature and absence of specified hazard details are consistent with precautionary recall action, supporting Moderate severity.
Plain-English summary
DeRoyal Industries Inc, located in Powell, Tennessee, is voluntarily recalling 45 units of the DeRoyal TOTAL HIP KIT (Reference 89-9498.10, Lot 57686947, expiration date 5/1/2025). This is a Class II medical device recall.
The recalled kits were distributed to healthcare facilities in 23 US states: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, and Mississippi.
The specific reason for the recall is not detailed in available FDA documentation. The FDA classified this as an ongoing recall, initially initiated by the firm on November 3, 2022.
Patients who have received this implant or healthcare facilities that have units of this product should contact DeRoyal Industries Inc for guidance.
The recalled product
- Product
- DeRoyal TOTAL HIP KIT, REF 89-9498.10
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- implant-defect
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 Numbers: Lot 57686947 exp 5/1/2025
Distribution
Distribution scope not specified by the agency.
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