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.
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: 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
- 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
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.
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