Medical Device Recall: DeRoyal Surgical Knee Pack Components
DeRoyal TOTAL KNEE PACK surgical kits are being recalled as a Class II device recall. The specific reason for recall is not documented in available source records.
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 medical device recall with no reported illnesses, injuries, or documented hazard. As a voluntary, firm-initiated recall without patient harm reports, it meets the criteria for Moderate severity per the rubric classification of 'voluntary precautionary recalls.'
Plain-English summary
DeRoyal Industries Inc has initiated a voluntary recall of the DeRoyal TOTAL KNEE PACK A & B PACK (REF 89-6799.02). This is a Class II medical device recall affecting 10 surgical kits.
The recall was initiated on November 3, 2022, and is classified as voluntary and firm-initiated. Affected lot 57749071 (expiring February 1, 2024) has been distributed to healthcare facilities 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.
The specific reason for this Class II recall is not documented in the available recall records. Healthcare facilities and providers who have received affected kits should contact DeRoyal Industries Inc at 200 Debusk Ln, Powell, Tennessee 37849 for further instructions regarding the affected inventory.
The recalled product
- Product
- DeRoyal TOTAL KNEE PACK A & B PACK, REF 89-6799.02
- 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 57749071 exp 2/1/2024
Distribution
Distribution scope not specified by the agency.
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