The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0694-2023·Announced 2022-12-21

DeRoyal Lumbar Disc Pack Medical Device Recalled as FDA Class II

DeRoyal Industries initiated a voluntary recall of 12 kits of Lumbar Disc Pack medical devices distributed across 23 US states. Specific hazard details from the FDA are not available in the source data.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II voluntary, firm-initiated recall with no reported illnesses or injuries documented in the source. The recall meets the rubric criteria for Moderate severity as a voluntary precautionary recall without evidence of harm.

Plain-English summary

DeRoyal Industries Inc voluntarily recalled its Lumbar Disc Pack medical devices, model REF 89-10605.02, affecting 12 kits in total. The products were distributed across 23 US 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 recall was initiated on November 3, 2022, by the manufacturer and classified by the FDA as Class II. Affected units are identified by two lot numbers: Lot 57241041 (expiration 2/1/2024) and Lot 57590494 (expiration 5/1/2024). The recall status remains listed as ongoing.

The manufacturer notified customers and distributors through multiple channels including email, fax, letter, press release, telephone contact, and direct visits. Specific details regarding the hazard or reason for the recall were not provided in the available FDA source documentation.

The recalled product

Product
DeRoyal LUMBAR DISC PACK, REF 89-10605.02
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical / Medical Equipment
Affected units
12

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 57241041 exp 2/1/2024
  • Lot 57590494 exp 5/1/2024

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 →

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