Medical device recall: DeRoyal TRACECART posterior lumbar fusion kits
DeRoyal is recalling 336 TRACECART surgical kits distributed across 23 US states. This is a voluntary, Class II recall initiated by the manufacturer.
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 an FDA Class II voluntary recall with no reported illnesses or injuries. The specific reason for recall is not disclosed in the source information, and as a manufacturer-initiated precautionary recall without reported harm, it meets the criteria for Moderate severity.
Plain-English summary
DeRoyal Industries Inc is recalling 336 TRACECART POSTEROR LUMBAR FUSION TRACECART kits (REF 53-1961.02). The affected units were distributed to medical facilities in 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 recall involves 23 specific lot numbers with expiration dates ranging from September 2023 to April 2024. This is a voluntary, manufacturer-initiated Class II recall.
Healthcare facilities and providers who received affected TRACECART kits should identify units by lot number and contact DeRoyal Industries Inc for guidance on recall procedures and next steps.
The recalled product
- Product
- DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART, REF 53-1961.02
- 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 (20)
- Lot Numbers: 56169083 exp 12/01/2023
- 56357092 exp 12/01/2023
- 56481018 exp 12/01/2023
- 56538205 exp 09/01/2023
- 56873265 exp 09/01/2023
- 56895966 exp 09/01/2023
- 56942611 exp 03/01/2024
- 57088584 exp 03/01/2024
- 57088592 exp 03/01/2024
- 57180516 exp 03/01/2024
- 57270562 exp 03/01/2024
- 57313163 exp 03/01/2024
- 57313171 exp 03/01/2024
- 57492608 exp 03/01/2024
- 57646152 exp 03/01/2024
- 57681329 exp 03/01/2024
- 57717598 exp 03/01/2024
- 57788708 exp 03/01/2024
- 57889681 exp 03/01/2024
- 57928563 exp 03/01/2024
Distribution
Distribution scope not specified by the agency.
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