The Recall Desk
HighFDA (Devices)·Z-0708-2023·Announced 2022-12-21

DeRoyal recalls Class II TRACECART POSTEROR LAMI MICRODISC device

DeRoyal Industries is recalling 72 kits of TRACECART POSTEROR LAMI MICRODISC TRACECART devices distributed across 23 U.S. states in a voluntary Class II recall initiated by the manufacturer.

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: This is a Class II medical device recall initiated voluntarily by the manufacturer. FDA Class II classification indicates potential for serious adverse health consequences, though no illnesses or injuries have been reported. This meets the High criteria as a risk-of-harm product without yet-reported patient harm.

Plain-English summary

DeRoyal Industries Inc. is voluntarily recalling 72 kits of the TRACECART POSTEROR LAMI MICRODISC TRACECART (Reference 53-1960.02). This is a Class II medical device recall that was initiated by the manufacturer on November 3, 2022, and reported to the FDA on December 21, 2022.

The recalled devices were distributed 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 affected lot numbers are: 56573668 (exp. 45170), 56670564 (exp. 45170), 56847198 (exp. 45170), 57564851 (exp. 45323), 57889672 (exp. 45323), and 58032515 (exp. 45323).

Consumers and healthcare providers who have received affected devices should contact DeRoyal Industries Inc. at 200 Debusk Lane, Powell, Tennessee 37849-4703 for additional information regarding the recalled devices.

The recalled product

Product
DeRoyal TRACECART POSTEROR LAMI MICRODISC TRACECART, REF 53-1960.02
Manufacturer
DeRoyal Industries Inc
Category
Medical Device
Affected units
72

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 (6)

  • Lot Numbers: 56573668 exp 45170
  • 56670564 exp 45170
  • 56847198 exp 45170
  • 57564851 exp 45323
  • 57889672 exp 45323
  • 58032515 exp 45323

Distribution

Distributed in 23 states:

Part of a larger recall action

This product is one of 156 recalled by DeRoyal Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 156 products in this recall →

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