DeRoyal TOTAL HIP KIT medical devices recalled by manufacturer
DeRoyal Industries is voluntarily recalling 51 units of the DeRoyal TOTAL HIP KIT (Lot 56187960 and 57031051) distributed to healthcare facilities across 23 US states.
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 voluntary recall initiated by the manufacturer. No hospitalizations or injuries are reported in the source document, and the recall is characterized as precautionary. These factors place it in the Moderate severity category.
Plain-English summary
DeRoyal Industries Inc is voluntarily recalling the DeRoyal TOTAL HIP KIT, Reference 89-9498.08. This recall affects 51 kits and was initiated on November 3, 2022.
Affected lot numbers are: - Lot 56187960 (expiration 12/4/2024) - Lot 57031051 (expiration 3/1/2025)
The kits were distributed to healthcare facilities in 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 this recall is not detailed in the available recall notice. No illnesses or injuries have been reported. The recall remains ongoing. Patients and healthcare providers with affected kits should contact DeRoyal Industries for further information and guidance.
The recalled product
- Product
- DeRoyal TOTAL HIP KIT, REF 89-9498.08
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 51
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)
- Lot Numbers: Lot 56187960 exp 12/4/2024
- Lot 57031051 exp 3/1/2025
Distribution
Part of a larger recall action
This product is one of 156 recalled by DeRoyal Industries Inc 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.
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