DeRoyal Shoulder Kit Subject to FDA Class II Recall
DeRoyal Industries Inc is recalling 14 shoulder kits (Lot 56580884, expiring 12/1/2024) distributed to healthcare facilities in 23 states. The company initiated a voluntary Class II recall with the FDA.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device recall indicates a potential for serious adverse health consequences. No injuries or illnesses are reported in the source documentation, fitting the rubric criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
DeRoyal Industries Inc, based in Powell, Tennessee, is recalling 14 units of the DeRoyal Shoulder Kit (REF 89-9497.08) in a Class II safety recall. The specific reason for the recall has not been disclosed in publicly available FDA documentation.
Affected lot number 56580884 expires December 1, 2024. These kits were distributed to healthcare facilities and providers across 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.
DeRoyal Industries initiated this recall voluntarily on November 3, 2022. Healthcare providers and distributors who have received this lot number should cease use and contact DeRoyal Industries Inc for further guidance on product return or replacement.
The recalled product
- Product
- DeRoyal SHOULDER KIT, REF 89-9497.08
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 14
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 56580884 exp 12/1/2024
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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