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TOTAL KNEE - 247546 Procedure tray Catalog Number: BFTK01Z

FDA Recall #Z-2279-2024 — Class II — May 15, 2024

Recall #Z-2279-2024 Date: May 15, 2024 Classification: Class II Status: Ongoing

Product Description

TOTAL KNEE - 247546 Procedure tray Catalog Number: BFTK01Z

Reason for Recall

Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.

Recalling Firm

American Contract Systems Inc — Tiffin, OH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

50 units

Distribution

US Nationwide distribution.

Code Information

UDI-DI: 00191072214614 LOT#"s: 983241

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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