Medical Device Recall: DeRoyal TOTAL KNEE PACK surgical kit
DeRoyal Industries recalled 48 kits of the TOTAL KNEE PACK surgical product in November 2022. The specific reason for the recall was not disclosed in the public notice.
What this means for you
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 medical device recalls indicate potential for serious adverse health consequences. This meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' with no documented illnesses or injuries.
Plain-English summary
DeRoyal Industries Inc initiated a voluntary recall of its TOTAL KNEE PACK (REF 89-9300.08) surgical kit in November 2022. The recall affected 48 kits with lot number 57198935, which had an expiration date of June 1, 2024.
The affected kits 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 Food and Drug Administration classified this recall as Class II, indicating potential for serious adverse health consequences. No illnesses or injuries have been reported. Healthcare facilities in the affected states that received these kits should contact DeRoyal Industries for recall instructions.
The recalled product
- Product
- DeRoyal TOTAL KNEE PACK, REF 89-9300.08
- 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 57198935 exp 6/1/2024
Distribution
Distribution scope not specified by the agency.
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