The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0693-2023·Announced 2022-12-21

DeRoyal Lumbar Disc Pack Medical Device Class II Recall

DeRoyal Industries initiated a voluntary recall of 6 kits of its Lumbar Disc Pack medical device distributed across 23 US states. The specific reason for recall was not detailed in the notice.

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: FDA Class II medical device recall initiated voluntarily with no reported illnesses or injuries. The specific reason for recall is not provided in the source material. Precautionary voluntary recalls without stated adverse events typically warrant moderate severity.

Plain-English summary

DeRoyal Industries Inc is recalling 6 kits of its Lumbar Disc Pack (Reference 89-10590.02) medical device. The recall was voluntarily initiated by the manufacturer and is classified as FDA Class II. The specific hazard or defect that prompted the recall is not detailed in the available source material.

The affected product lot is Lot 57022219, with an expiration date of 3/1/2024. The recall affects devices 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.

Consumers or healthcare facilities that have received this device should contact DeRoyal Industries Inc or refer to FDA communications for further instructions. The recall communications were reportedly distributed via email, fax, letter, press release, telephone, or direct facility visits.

The recalled product

Product
DeRoyal LUMBAR DISC PACK, REF 89-10590.02
Manufacturer
DeRoyal Industries Inc
Category
Medical Device
Affected units
6

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 57022219 exp 3/1/2024

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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