Knee Scope Procedure Tray Recalled for Excess Sterilization Residue Levels
American Contract Systems Inc. is recalling KNEE SCOPE Procedure Tray kits because ethylene oxide sterilization residues in the cast padding component exceed safe exposure limits per FDA and ISO standards.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with potential biocompatibility risk due to sterilization residues exceeding ISO standards for permanent-use medical devices. No reported illnesses or injuries as of the recall notice; however, the hazard poses a direct risk to patient safety if the device is used clinically.
Plain-English summary
American Contract Systems Inc. is recalling KNEE SCOPE Procedure Tray kits (Catalog Number COKN48L) distributed nationwide. The affected trays contain ethylene oxide (EO) and ethylene chlorohydrin (ECH) sterilization residues in the cast padding component that exceed the allowable limits established by ANSI/AAMI/ISO 10993-7 standards for permanent-use medical devices.
The recall affects 36 units with lot numbers 644231, 955241, and 915241 (UDI-DI: 00191072176301). Excess sterilization residues can potentially compromise the biocompatibility of the device and pose risks to patient tissue during clinical use.
Healthcare facilities and practitioners using these tray kits should immediately discontinue use and contact American Contract Systems Inc. for replacement or refund information.
The recalled product
- Product
- KNEE SCOPE Procedure tray Catalog Number: COKN48L
- Manufacturer
- American Contract Systems Inc
- 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 (1)
- UDI-DI: 00191072176301 LOT#"s: 644231 955241 915241
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 39 recalled by American Contract Systems 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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