Medical device shoulder arthroscopy surgical cart voluntary recall issued
DeRoyal has voluntarily recalled 117 TRACECART shoulder arthroscopy kits distributed across 23 U.S. states. No illnesses or injuries have been reported. The specific reason for the recall is not disclosed in available 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: FDA Class II medical device recall initiated voluntarily by the manufacturer with no reported illnesses or injuries. This is classified as a precautionary recall; the specific safety hazard has not been disclosed in available documentation.
Plain-English summary
DeRoyal Industries Inc has initiated a voluntary recall of 117 TRACECART shoulder arthroscopy kits (Model REF 53-1962.02). The devices were distributed to hospitals and surgical facilities 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 specific reason for this recall has not been disclosed in the available FDA documentation.
The recall involves nine specific lot numbers with expiration dates ranging from October 2023 through February 2024: 56296761 (exp. 10/01/2023), 56717318 (exp. 11/01/2023), 57136671 (exp. 11/01/2023), 57225673 (exp. 11/01/2023), 57225817 (exp. 02/01/2024), 57455920 (exp. 02/01/2024), 57646161 (exp. 02/01/2024), 57889699 (exp. 02/01/2024), and 58003853 (exp. 02/01/2024).
Healthcare facilities that received these devices should contact DeRoyal Industries Inc at 200 DeBusk Lane, Powell, TN 37849-4703 for further instructions. No illnesses or injuries have been reported in association with this recall.
The recalled product
- Product
- DeRoyal TRACECART SHOULDER ARTHROSCOPY TRACECART, REF 53-1962.02
- 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 (9)
- Lot Numbers: 56296761 exp 10/01/2023
- 56717318 exp 11/01/2023
- 57136671 exp 11/01/2023
- 57225673 exp 11/01/2023
- 57225817 exp 02-01-2024
- 57455920 exp 02-01-2024
- 57646161 exp 02-01-2024
- 57889699 exp 02-01-2024
- 58003853 exp 02-01-2024
Distribution
Distribution scope not specified by the agency.
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