FDA Class II recall: DeRoyal posterior laminectomy microdisc pack
DeRoyal Industries initiated a recall of its POSTERIOR LAMI MICRODISC PACK, an FDA Class II medical device. The reason for this recall was not disclosed in available documentation.
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 an FDA Class II recall initiated voluntarily by the manufacturer with no reported illnesses, injuries, or deaths documented. Without disclosed hazard information and with no reported harm, this qualifies as a voluntary precautionary recall, consistent with Moderate severity.
Plain-English summary
DeRoyal Industries Inc initiated a recall of its POSTERIOR LAMI MICRODISC PACK (REF 89-10059.02) in November 2022. This FDA Class II recall was firm-initiated and remains ongoing as of the available documentation.
The specific reason for the recall was not disclosed in the source material. Two lot numbers are affected: Lot 57288181 (expires 2/1/2024) and Lot 56665247 (expires 9/1/2023).
The product was distributed 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. Healthcare facilities that received affected lot numbers should monitor for guidance from the manufacturer regarding this ongoing recall.
The recalled product
- Product
- DeRoyal POSTERIOR LAMI MICRODISC PACK, REF 89-10059.02
- 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 (2)
- Lot Numbers: Lot 57288181 exp 2/1/2024
- Lot 56665247 exp 9/1/2023
Distribution
Distribution scope not specified by the agency.
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