The Recall Desk
ModerateFDA (Devices)·Z-0634-2023·Announced 2022-12-21

DeRoyal Hip Pack Medical Device Recall - Reason Unspecified

DeRoyal Industries Inc recalled 16 kits of DeRoyal TOTAL HIP PACK (Lot 56042728, expiring May 1, 2026) distributed across 23 U.S. states. The specific reason for the recall was not provided in available agency documentation.

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 recall designated as voluntary and firm-initiated with no reported illnesses, injuries, or deaths. The absence of documented specific hazards or patient harm, combined with voluntary precautionary status, places this in the Moderate category per the severity rubric.

Plain-English summary

DeRoyal Industries Inc initiated a voluntary recall of its DeRoyal TOTAL HIP PACK, REF 89-9113.06 on November 3, 2022. The product is a surgical kit distributed across 23 U.S. 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 recall involves 16 kits with Lot Number 56042728 expiring May 1, 2026. The specific reason for the recall was not documented in available records. This is a Class II recall, classified and initiated by the firm.

Healthcare facilities and medical professionals who received this product should review their inventory and consult DeRoyal Industries Inc and FDA guidance regarding whether the product should be used, quarantined, or replaced. No reported injuries or illnesses have been documented in association with this recall.

The recalled product

Product
DeRoyal TOTAL HIP PACK, REF 89-9113.06
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Orthopedic Surgical Kit
Affected units
16

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 56042728 exp 5/1/2026

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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