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.
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 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
- 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
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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