The Recall Desk
HighFDA (Devices)·Z-0626-2023·Announced 2022-12-21

DeRoyal TLIF Procedure Packs Recalled Due to Included 3M Steri Drapes

DeRoyal TLIF procedure packs containing recalled 3M Health Care Steri Drapes are being recalled. The affected packs were distributed across multiple 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: FDA Class II recall with no reported illnesses or injuries. The recall involves a risk-of-harm product—surgical procedure packs containing separately recalled components—where injury has not yet been reported.

Plain-English summary

DeRoyal Industries Inc is recalling DeRoyal TLIF PACK (REF 89-8780.04) procedure packs that contain 3M Health Care Steri Drapes, which have been separately recalled by 3M. A total of 64 kits are affected.

The recalled procedure packs were distributed across the United States, including 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 affected lot numbers are Lot 56020431 (expiration 9/1/2023) and Lot 56390757 (expiration 1/1/2024). Healthcare facilities and surgical centers that received these procedure packs should immediately stop using them and contact DeRoyal Industries Inc for instructions on return or replacement.

The recalled product

Product
DeRoyal TLIF PACK, REF 89-8780.04
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical Procedure Pack

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 56020431 exp 9/1/2023
  • Lot 56390757 exp 1/1/2024

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category