The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0646-2023·Announced 2022-12-21

DeRoyal TOTAL HIP PACK medical device recall, 85 kits

DeRoyal Industries Inc is recalling 85 kits of its TOTAL HIP PACK surgical device (Ref 89-9301.07). The reason for recall was not disclosed. The recall affects 22 US states with two specific lot numbers.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II surgical medical device recall initiated by the firm. While the specific hazard is not disclosed and no illnesses or injuries are reported, the active recall of a surgical device indicates an identified risk of harm. Per the rubric: 'risk-of-harm products where injury has not yet been reported' rates as High (Score 3).

Plain-English summary

DeRoyal Industries Inc is recalling 85 kits of its TOTAL HIP PACK, Reference 89-9301.07, a surgical orthopedic device used in hip replacement procedures. The reason for the recall has not been disclosed in the available source material.

The recall is voluntary and was initiated by the firm. It affects two lot numbers: Lot 56186932 (expiration 2/1/2025) and Lot 57091222 (expiration 3/1/2025). The FDA classified the recall as Class II on December 15, 2022, with recall initiation beginning November 3, 2022.

The recalled kits have been distributed across 22 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, and Georgia.

Persons or facilities in possession of the affected kits should contact DeRoyal Industries Inc at the recall initiation address (200 Debusk Ln, Powell, TN 37849) for further instructions.

The recalled product

Product
DeRoyal TOTAL HIP PACK, REF 89-9301.07
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical / Orthopedic
Affected units
85

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 56186932 exp 2/1/2025
  • Lot 57091222 exp 3/1/2025

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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