DeRoyal Lumbar Disc Pack Medical Device Recalled as FDA Class II
DeRoyal Industries initiated a voluntary recall of 12 kits of Lumbar Disc Pack medical devices distributed across 23 US states. Specific hazard details from the FDA are not available in the source data.
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 voluntary, firm-initiated recall with no reported illnesses or injuries documented in the source. The recall meets the rubric criteria for Moderate severity as a voluntary precautionary recall without evidence of harm.
Plain-English summary
DeRoyal Industries Inc voluntarily recalled its Lumbar Disc Pack medical devices, model REF 89-10605.02, affecting 12 kits in total. The products were distributed across 23 US 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 recall was initiated on November 3, 2022, by the manufacturer and classified by the FDA as Class II. Affected units are identified by two lot numbers: Lot 57241041 (expiration 2/1/2024) and Lot 57590494 (expiration 5/1/2024). The recall status remains listed as ongoing.
The manufacturer notified customers and distributors through multiple channels including email, fax, letter, press release, telephone contact, and direct visits. Specific details regarding the hazard or reason for the recall were not provided in the available FDA source documentation.
The recalled product
- Product
- DeRoyal LUMBAR DISC PACK, REF 89-10605.02
- 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 57241041 exp 2/1/2024
- Lot 57590494 exp 5/1/2024
Distribution
Distribution scope not specified by the agency.
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