DeRoyal ORTHO SPINE BACK PACK Medical Device Recall
DeRoyal Industries is recalling 264 units of the ORTHO SPINE BACK PACK orthopedic device across 23 U.S. states as a voluntary, Class II recall. The specific reason for the recall is not provided in the available 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: This is a Class II voluntary medical device recall initiated by the manufacturer. No reported illnesses, injuries, or deaths are documented in the source, and the specific reason for the recall is not provided, indicating a precautionary or administrative issue rather than an imminent safety hazard.
Plain-English summary
DeRoyal Industries Inc is recalling 264 kits of the DeRoyal ORTHO SPINE BACK PACK (Reference 89-7534.09), an orthopedic spinal support device. The manufacturer initiated this voluntary recall on November 3, 2022, and it was classified by the FDA on December 15, 2022, as a Class II recall.
The affected products were 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. The recalled units are identified by two lot numbers: Lot 57197297 (expiration 3/1/1024) and Lot 57746479 (expiration 5/1/2024).
The specific reason for this recall has not been provided in the available notice. The manufacturer notified recipients through email, fax, letter, press release, telephone contact, and in-person visits. As of the report date of December 21, 2022, the recall status was ongoing. Consumers who have received this product should contact DeRoyal Industries Inc for information regarding the recall and any necessary actions.
The recalled product
- Product
- DeRoyal ORTHO SPINE BACK PACK, REF 89-7534.09
- 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 (2)
- Lot Numbers: Lot 57197297 exp 3/1/1024
- Lot 57746479 exp 5/1/2024
Distribution
Distribution scope not specified by the agency.
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