The Recall Desk
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.

What this means for you

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

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

Distribution scope not specified by the agency.

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