The Recall Desk
ModerateFDA (Devices)·Z-0632-2023·Announced 2022-12-21

FDA Class II Recall: DeRoyal Laminectomy Spinal Fusion Surgical Packs

DeRoyal Industries has voluntarily recalled 90 kits of laminectomy spinal fusion surgical packs. The recall affects units distributed across 23 U.S. states. The specific reason for recall was not disclosed in available materials.

What this means for you

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, firm-initiated Class II FDA recall. The source does not report any illnesses or injuries. Per the severity rubric, Class II recalls without reported harm and with no disclosed hazard details warrant a Moderate (2) rating.

Plain-English summary

DeRoyal Industries Inc has issued a voluntary recall of its LAMINECTOMY SPINAL FUSION PACK (Reference 89-9105.09), initiated by the firm. The recall involves 90 kits that were distributed to healthcare facilities across 23 U.S. 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 U.S. Food and Drug Administration has classified this as a Class II recall. The specific reason for the recall was not disclosed in available materials.

Affected units are identified by Lot Number 56973098 with an expiration date of June 1, 2024. Healthcare providers and institutions that received these units should identify inventory with this lot number and follow DeRoyal Industries' instructions for return or replacement.

The recalled product

Product
DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.09
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical Implant / Spinal Fusion
Affected units
90

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 56973098 exp 6/1/2024

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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