The Recall Desk
ModerateFDA (Devices)·Z-0666-2023·Announced 2022-12-21

Medical Device Recall: DeRoyal Shoulder Arthroscopy Pack Kits

DeRoyal Industries initiated a voluntary recall of 363 shoulder arthroscopy surgical packs. The specific reason for the recall was not disclosed in the notice.

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 precautionary recall initiated by the manufacturer with no reported illnesses, injuries, or deaths. The specific hazard was not disclosed in the recall notice. Voluntary recalls without evidence of harm fall within the Moderate severity category.

Plain-English summary

DeRoyal Industries Inc has initiated a voluntary recall of the DeRoyal SHOULDER ARTHROSCOPY PACK (Model REF 89-9946.04). The recall affects 363 surgical kits from three production lots.

The affected lots are: Lot 56394580 (expiration 10/1/2024), Lot 56780181 (expiration 12/1/2024), and Lot 56822791 (expiration 11/1/2024). The specific reason for the recall was not disclosed in the recall documentation.

The recalled kits were distributed to healthcare facilities in 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 providers and hospitals that received these kits should contact DeRoyal Industries Inc at their Powell, Tennessee facility or through their medical device supplier for handling instructions regarding the recalled products.

The recalled product

Product
DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-9946.04
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Orthopedic
Affected units
363

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 (3)

  • Lot Numbers: Lot 56394580 exp 10/1/2024
  • Lot 56780181 exp12/1/2024
  • Lot 56822791 exp 11/1/2024

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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