The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0635-2023·Announced 2022-12-21

DeRoyal hip surgical pack recalled in voluntary Class II action

DeRoyal Industries is recalling 8 kits of its TOTAL HIP PACK (Lot 57460930) distributed across 23 U.S. states in a voluntary Class II FDA recall.

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 Class II FDA device recall represents a risk-of-harm product per the regulatory classification. Although no illnesses or injuries have been reported, Class II status indicates significant FDA concern for the product's safety or effectiveness.

Plain-English summary

DeRoyal Industries Inc is recalling 8 kits of its DeRoyal TOTAL HIP PACK, model REF 89-9113.07, lot 57460930 (expiration February 1, 2026). The surgical packs were distributed to medical facilities across 23 U.S. states.

The firm initiated this voluntary recall on November 3, 2022. The FDA classified it as Class II on December 15, 2022. The manufacturer notified affected facilities through multiple channels including email, fax, letter, press release, telephone, and in-person visits.

The recalled product

Product
DeRoyal TOTAL HIP PACK, REF 89-9113.07
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Hip Surgery / Surgical Packs
Affected units
8

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 57460930 exp 2/1/2026

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 →

Related recalls

Same manufacturer · DeRoyal Industries Inc

See all →

Similar recalls