The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0704-2023·Announced 2022-12-21

Medical Device Recall: DeRoyal Surgical Knee Pack Components

DeRoyal TOTAL KNEE PACK surgical kits are being recalled as a Class II device recall. The specific reason for recall is not documented in available source records.

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 a Class II medical device recall with no reported illnesses, injuries, or documented hazard. As a voluntary, firm-initiated recall without patient harm reports, it meets the criteria for Moderate severity per the rubric classification of 'voluntary precautionary recalls.'

Plain-English summary

DeRoyal Industries Inc has initiated a voluntary recall of the DeRoyal TOTAL KNEE PACK A & B PACK (REF 89-6799.02). This is a Class II medical device recall affecting 10 surgical kits.

The recall was initiated on November 3, 2022, and is classified as voluntary and firm-initiated. Affected lot 57749071 (expiring February 1, 2024) has been distributed to healthcare facilities 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 specific reason for this Class II recall is not documented in the available recall records. Healthcare facilities and providers who have received affected kits should contact DeRoyal Industries Inc at 200 Debusk Ln, Powell, Tennessee 37849 for further instructions regarding the affected inventory.

The recalled product

Product
DeRoyal TOTAL KNEE PACK A & B PACK, REF 89-6799.02
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Orthopedic Surgical Supplies
Affected units
10

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 57749071 exp 2/1/2024

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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