TOTAL KNEE Procedure Tray Recalled for Ethylene Oxide Sterilization Residuals
American Contract Systems is recalling TOTAL KNEE procedure trays (Catalog BFTK01Z, lot 983241) due to ethylene oxide and ethylene chlorohydrin residuals exceeding regulatory limits for permanent-use medical devices.
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: Class II FDA recall for documented sterilization residual non-compliance on a permanent-use medical device, but with no reported injuries or illnesses. Per the severity rubric, risk-of-harm products without reported injury score at most High (3).
Plain-English summary
American Contract Systems Inc. is recalling TOTAL KNEE procedure trays (Catalog Number BFTK01Z) with lot number 983241. Approximately 50 units were distributed nationwide to healthcare facilities.
The recall was initiated because ethylene oxide and ethylene chlorohydrin residuals on the cast padding component exceeded the limits for permanent-use medical devices as specified in ANSI/AAMI/ISO 10993-7 (R)2012. Ethylene oxide is used in the sterilization process; federal standards require residual concentrations to remain below specified levels.
Healthcare facilities and surgical centers using these procedure trays should immediately discontinue use and contact American Contract Systems Inc. for information regarding returns or replacement products.
The recalled product
- Product
- TOTAL KNEE - 247546 Procedure tray Catalog Number: BFTK01Z
- Manufacturer
- American Contract Systems Inc
- Hazard
- Affected units
- 50
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: 00191072214614 LOT#"s: 983241
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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