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
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
Distribution scope not specified by the agency.
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