The Recall Desk
ModerateFDA (Devices)·Z-0678-2023·Announced 2022-12-21

DeRoyal laminectomy surgical instrument kits subject to Class II recall

DeRoyal Industries is recalling LAMINECTOMY PACK surgical kits (Lot 56388471) distributed in multiple US states. Healthcare facilities with affected kits should verify their inventory and contact the manufacturer for guidance.

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 a voluntary FDA Class II medical device recall with no reported injuries or illnesses. The specific hazard has not been identified in available information. In the absence of reported adverse events, this appears to be a precautionary recall initiated by the manufacturer.

Plain-English summary

DeRoyal Industries Inc has issued a voluntary recall of the DeRoyal LAMINECTOMY PACK surgical instrument kit (Reference 89-10209.02). Twelve kits from Lot 56388471, expiring 6/1/2026, are subject to this recall.

The affected kits have been distributed to healthcare facilities across multiple US 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.

DeRoyal Industries initiated this recall voluntarily and notified customers through multiple channels including email, fax, letter, press release, telephone, and direct visits. Healthcare facilities that may have received these kits should verify their inventory against the affected lot number and contact DeRoyal Industries for guidance on proper handling or return procedures.

The recalled product

Product
DeRoyal LAMINECTOMY PACK, REF 89-10209.02
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical instruments
Affected units
12

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 (1)

  • Lot Numbers: Lot 56388471 exp 6/1/2026

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 →

Related recalls

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