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Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01

FDA Recall #Z-0569-2024 — Class II — November 2, 2023

Recall #Z-0569-2024 Date: November 2, 2023 Classification: Class II Status: Ongoing

Product Description

Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01

Reason for Recall

One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device.

Recalling Firm

Biomet, Inc. — Warsaw, IN

Classification

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

Product Type

Devices

Product Quantity

10 units

Distribution

US States: AL, CA, MD, MI, NC, OH, OK, TN, TX. Netherlands.

Code Information

UDI-DI: 00889024430556; Lot Number: 3145299

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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