DeRoyal Orthopedic Kit Recalled; Reason Not Specified in Notice
DeRoyal MAJOR ORTHO PACK kits (Ref 89-9250.07) are being voluntarily recalled. The specific reason is not provided in the FDA notice. Affected lots were distributed across 23 U.S. states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: Voluntary Class II medical device recall with no reported illnesses, injuries, or stated hazard reason. Per the severity rubric, voluntary precautionary recalls without reported harm score 2 (Moderate).
Plain-English summary
DeRoyal Industries Inc is voluntarily recalling the MAJOR ORTHO PACK (Reference 89-9250.07), a medical device kit. The recall affects 48 kits with two lot numbers: Lot 56388551 (expiration 10/1/2024) and Lot 56780333 (expiration 3/1/2025).
The specific reason for this recall is not provided in the FDA notice. The recall was initiated on November 3, 2022, and the FDA was notified on December 15, 2022. DeRoyal notified customers through multiple channels including email, fax, letter, press release, telephone, and direct visits.
Affected units were distributed to customers 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.
If you have received kits from the affected lot numbers, contact DeRoyal Industries Inc for further instructions. This is a Class II recall, indicating a moderate-risk situation.
The recalled product
- Product
- DeRoyal MAJOR ORTHO PACK, REF 89-9250.07
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 48
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 56388551 exp 10/1/2024
- Lot 56780333 exp 3/1/2025
Distribution
Part of a larger recall action
This product is one of 156 recalled by DeRoyal Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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