The Recall Desk
ModerateFDA (Devices)·Z-0578-2023·Announced 2022-12-21

Medical device recall: GEO-MED Total Knee Pack surgical kits

DeRoyal Industries voluntarily recalled 49 kits of the GEO-MED TOTAL KNEE PACK A & B distributed across 23 U.S. states. The specific reason for the recall is not detailed in the FDA 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: Class II voluntary device recall with no reported illnesses, injuries, or deaths documented in the source. Voluntary recalls without documented harm typically receive a Moderate classification per FDA guidance.

Plain-English summary

DeRoyal Industries Inc initiated a voluntary recall of the GEO-MED TOTAL KNEE PACK A & B (REF 89-6799.02) on November 3, 2022. The recall affected 49 kits 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.

The specific reason for this recall is not stated in the FDA agency notice. Five lot numbers have been identified with expiration dates ranging from July 2023 to February 2024.

This is a Class II voluntary recall initiated by the manufacturer. Consumers or healthcare facilities who received this product should contact DeRoyal Industries Inc or their distributor for instructions on next steps.

The recalled product

Product
GEO-MED TOTAL KNEE PACK A & B, REF 89-6799.02
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Orthopedic surgical kits
Affected units
49

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 (5)

  • Lot Numbers: Lot 55441428 exp 7/1/2023
  • Lot 55966742 exp 10/1/2023
  • Lot 56777898 exp 12/1/2023
  • Lot 57391081 exp 2/1/2024
  • Lot 57748071 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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