FDAClass IIDecember 21, 2022

Deroyal Tracecart Posteror Lumbar Fusion Tracecart recall

DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART, REF 53-1961.02

Why was Deroyal Tracecart Posteror Lumbar Fusion Tracecart recalled?

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What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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; 57960070 exp 03/01/2024; 58003845 exp 04/01/2024; 58032523 exp 04/01/2024

Product
DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART, REF 53-1961.02
Recalling firm
DeRoyal Industries Inc
Quantity
336 kits
Distribution
US: 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, Mississippi
Recall date
December 21, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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