Surgical Device Recall: DeRoyal Shoulder Arthroscopy Pack
DeRoyal Industries initiated a voluntary recall of its Shoulder Arthroscopy Pack (32 kits, Lot 56865450) distributed to healthcare facilities in 23 U.S. states. The specific reason for recall is not disclosed in FDA documentation.
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 FDA recall initiated voluntarily by the manufacturer. No hospitalizations, injuries, or illnesses are reported in the available FDA documentation. Classification as Moderate reflects the voluntary, precautionary nature of the recall and the absence of disclosed adverse health outcomes.
Plain-English summary
DeRoyal Industries Inc is recalling its Shoulder Arthroscopy Pack, model REF 89-10820.02. The affected product consists of 32 surgical kits from Lot 56865450, which expire January 1, 2024. The recall was initiated by the manufacturer on November 3, 2022, and is classified as a Class II recall.
The product was distributed to healthcare providers 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 FDA documentation does not disclose the specific reason for this voluntary recall. Healthcare facilities that received this product should contact DeRoyal Industries for further guidance. The manufacturer notified recipients through multiple channels including email, fax, letter, press release, telephone, and direct facility visits.
The recalled product
- Product
- DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10820.02
- 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 (1)
- Lot Numbers: Lot 56865450 exp 1/1/2024
Distribution
Distribution scope not specified by the agency.
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