The Recall Desk
HighFDA (Devices)·Z-0670-2023·Announced 2022-12-21

Surgical Spinal Fusion Device Recalled Across 23 US States

DeRoyal is recalling its Posterior Lumbar Fusion Pack medical device across 23 states. The voluntary recall affects specific lot numbers; patients should consult their healthcare provider.

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 is an FDA Class II surgical device with unspecified defects affecting a risk-of-harm product (spinal implant). No illnesses or injuries have been reported, limiting the score to a maximum of 3 per the rubric criterion for risk-of-harm products without reported injury.

Plain-English summary

DeRoyal Industries Inc is voluntarily recalling the DeRoyal Posterior Lumbar Fusion Pack (Reference 89-10060.02), a surgical device used in spinal fusion procedures. The recall was initiated on November 3, 2022, and publicly announced on December 21, 2022.

The recall affects four lot numbers: Lot 56395179 (expiration 12/1/2023), Lot 56431133 (expiration 9/1/2023), Lot 57190554 (expiration 3/1/2024), and Lot 5740754 (expiration 4/1/2024). These devices were distributed across 23 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 specific reason for the recall is not detailed in publicly available FDA records. Patients who have received this device or healthcare providers should verify whether their devices are among the affected lot numbers and contact DeRoyal Industries Inc or the FDA for further guidance.

The recalled product

Product
DeRoyal POSTERIOR LUMBAR FUSION PACK, REF 89-10060.02
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Spinal Implant
Hazard
  • device-defect

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 (4)

  • Lot Numbers: Lot 56395179 exp 12/1/2023
  • Lot 56431133 exp 9/1/2023
  • Lot 57190554 exp 3/1/2024
  • Lot 5740754 exp 4/1/2024

Distribution

Distribution scope not specified by the agency.

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