DeRoyal Lumbar Disc Pack Medical Device Class II Recall
DeRoyal Industries initiated a voluntary recall of 6 kits of its Lumbar Disc Pack medical device distributed across 23 US states. The specific reason for recall was not detailed in the notice.
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: FDA Class II medical device recall initiated voluntarily with no reported illnesses or injuries. The specific reason for recall is not provided in the source material. Precautionary voluntary recalls without stated adverse events typically warrant moderate severity.
Plain-English summary
DeRoyal Industries Inc is recalling 6 kits of its Lumbar Disc Pack (Reference 89-10590.02) medical device. The recall was voluntarily initiated by the manufacturer and is classified as FDA Class II. The specific hazard or defect that prompted the recall is not detailed in the available source material.
The affected product lot is Lot 57022219, with an expiration date of 3/1/2024. The recall affects devices 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.
Consumers or healthcare facilities that have received this device should contact DeRoyal Industries Inc or refer to FDA communications for further instructions. The recall communications were reportedly distributed via email, fax, letter, press release, telephone, or direct facility visits.
The recalled product
- Product
- DeRoyal LUMBAR DISC PACK, REF 89-10590.02
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device
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 57022219 exp 3/1/2024
Distribution
Distribution scope not specified by the agency.
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