The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0669-2023·Announced 2022-12-21

FDA Class II recall: DeRoyal posterior laminectomy microdisc pack

DeRoyal Industries initiated a recall of its POSTERIOR LAMI MICRODISC PACK, an FDA Class II medical device. The reason for this recall was not disclosed in available documentation.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 recall initiated voluntarily by the manufacturer with no reported illnesses, injuries, or deaths documented. Without disclosed hazard information and with no reported harm, this qualifies as a voluntary precautionary recall, consistent with Moderate severity.

Plain-English summary

DeRoyal Industries Inc initiated a recall of its POSTERIOR LAMI MICRODISC PACK (REF 89-10059.02) in November 2022. This FDA Class II recall was firm-initiated and remains ongoing as of the available documentation.

The specific reason for the recall was not disclosed in the source material. Two lot numbers are affected: Lot 57288181 (expires 2/1/2024) and Lot 56665247 (expires 9/1/2023).

The product was 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. Healthcare facilities that received affected lot numbers should monitor for guidance from the manufacturer regarding this ongoing recall.

The recalled product

Product
DeRoyal POSTERIOR LAMI MICRODISC PACK, REF 89-10059.02
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical / Orthopedic

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 (2)

  • Lot Numbers: Lot 57288181 exp 2/1/2024
  • Lot 56665247 exp 9/1/2023

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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