DeRoyal Laminectomy Spinal Fusion Surgical Pack Recall (Class II)
DeRoyal Industries is recalling 180 kits of laminectomy spinal fusion surgical packs distributed across 23 states. The reason for recall is not specified in the available source.
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 Class II medical device recall with no reported illnesses or injuries. Because the specific reason for recall is not documented and no harm is reported, the severity is set at moderate per the rubric.
Plain-English summary
DeRoyal Industries Inc is recalling approximately 180 kits of the DeRoyal LAMINECTOMY SPINAL FUSION PACK, Reference 89-9105.08. These surgical packs were distributed to medical facilities in 23 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 specific reason for this recall has not been documented in the available source material. The recall was initiated voluntarily by DeRoyal Industries Inc and is classified as Class II by the FDA. The recall was initiated on November 3, 2022, and remains ongoing.
The affected product includes Lot Numbers 56066279 (expiration 6/1/2024) and Lot 56631186 (expiration 6/1/2024). Medical facilities with these lots should contact DeRoyal Industries Inc for specific guidance regarding their inventory and any necessary actions.
The recalled product
- Product
- DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.08
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- device-defect
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 (2)
- Lot Numbers: Lot 56066279 exp 6/1/2024
- Lot 56631186 exp 6/1/2024
Distribution
Distribution scope not specified by the agency.
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