The Recall Desk
HighFDA (Devices)·Z-0598-2023·Announced 2022-12-21

DeRoyal Spinal Fusion Procedure Packs Recalled for 3M Drape Issue

DeRoyal spinal fusion procedure packs containing recalled 3M Health Care Steri Drapes are being recalled. Affected kits were distributed to healthcare facilities across 23 U.S. states.

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 medical device recall involves sterile surgical supplies where potential hazards exist but no illnesses or injuries are reported in the source documentation. The classification reflects the risk associated with surgical kits used in spinal procedures.

Plain-English summary

DeRoyal Industries Inc. is recalling approximately 30 spinal fusion procedure packs (Reference 89-7515.14, Lot 57746997, expiration date 12/1/2026) because they contain 3M Health Care Steri Drapes that have been subject to recall.

The affected procedure packs were distributed to healthcare facilities 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 recalled product

Product
DeRoyal SPINAL FUSION PACK, REF 89-7515.14
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical Kit
Hazard
  • sterility-concern

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 57746997 exp 12/1/2026

Distribution

Distribution scope not specified by the agency.

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