The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0679-2023·Announced 2022-12-21

DeRoyal Lumbar Fusion Pack Subject to FDA Class II Recall

DeRoyal Industries initiated a voluntary Class II recall of its Lumbar Fusion Pack (51 kits) distributed across 23 US states. The specific reason for the recall was not documented in available records.

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 a voluntary FDA Class II recall with no reported illnesses, injuries, or deaths. While Class II designation indicates potential for adverse health consequences, the absence of documented harm and the voluntary nature of the recall support a Moderate severity score rather than a higher classification.

Plain-English summary

DeRoyal Industries Inc has recalled the DeRoyal Lumbar Fusion Pack, REF 89-10211.05, in a voluntary FDA Class II recall. A total of 51 kits were distributed across 23 US 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 recall was initiated on November 3, 2022, and remains ongoing.

The FDA classified this product under Class II, which indicates a potential for adverse health consequences. However, the specific reason for the recall is not documented in the publicly available record. No illnesses, injuries, or deaths have been reported in association with this recall.

The affected lot is Lot 57714741 with an expiration date of August 1, 2024. Healthcare providers and facilities that may have received this product should verify their inventory against this lot number and contact DeRoyal Industries or the FDA for further guidance.

The recalled product

Product
DeRoyal LUMBAR FUSION PACK, REF 89-10211.05
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical Implant
Affected units
51

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 57714741 exp 8/1/2024

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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