The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0658-2023·Announced 2022-12-21

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.

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: 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
Category
Medical Device — Hip replacement implant
Hazard
Affected units
45

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

Distributed in 23 states:

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.

See all 156 products in this recall →

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