Total Knee Pack Medical Kits Recalled for Incorrect Expiration Date
American Contract Systems is recalling 36 Total Knee Pack medical convenience kits distributed to Massachusetts due to an incorrect expiration date on the product labeling.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 III recall involving a labeling error—specifically an incorrect expiration date on medical device packaging. No illnesses or injuries have been reported, making this a minor labeling error with theoretical risk.
Plain-English summary
American Contract Systems, Inc. is recalling 36 Total Knee Pack medical convenience kits (REF CETJ130, Lot 967231) distributed to Massachusetts. The recall is due to an incorrect expiration date printed on the product label.
The product label contains an incorrect expiration date, which could result in use of the device past its actual safe-use period and may compromise product integrity and sterility.
Consumers who have this product should verify the lot number (967231) and contact American Contract Systems, Inc. or their healthcare provider with questions about their supply.
The recalled product
- Product
- Total Knee Pack, REF CETJ130, medical convenience kits
- Manufacturer
- American Contract Systems, Inc.
- Category
- Medical Device — Surgical Kit
- Affected units
- 36
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 (2)
- UDI/DI: 00191072179593
- Lot Number: 967231
Distribution
Distributed in 1 state:
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