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.
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, 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
- 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
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 →Related recalls
Same manufacturer · DeRoyal Industries Inc
See all →- ModerateDeRoyal Myocardial Probe Recall Due to Incorrect Needle Length
FDA (Devices) · 2026-09-30
- ModerateVascular Access Dressing Recalled Due to Lack of Sterility Assurance
FDA (Devices) · 2026-06-10
- HighDeRoyal Suction Connector Tubing Recalled for Assembly and Function Issues
FDA (Devices) · 2025-03-12
- HighDeRoyal AMG Suction Connector Tubing connection may fail to seal
FDA (Devices) · 2025-02-26
- HighDeRoyal Children's Orthopedic Tracepack Smoke Evacuation Pencil Malfunction Recall
FDA (Devices) · 2024-11-13
Similar recalls
- HighSpine and laminectomy packs recalled after being sterilized more than once
FDA (Devices) · 2025-10-22
- HighSurgical Procedure Packs Recalled Due to Included Light Handle Covers
FDA (Devices) · 2023-06-14
- ModerateDeRoyal Knee Arthroscopy Pack Recalled Due to Component Recall
FDA (Devices) · 2014-08-06
- HighDeRoyal Custom Surgical Packs Recalled for Sterility Barrier Defect
FDA (Devices) · 2019-07-24
- HighDeRoyal surgical procedure pack recalled for sterile barrier defect
FDA (Devices) · 2023-01-18
- HighMedline Recalls Neurosurgical Convenience Kits Due to Contamination
FDA (Devices) · 2026-09-02