Recall Z-0569-2024— Biomet, Inc.

Name: FDA recall Z-0569-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-02

Class II · Ongoing

Class II FDA medical device recall by Biomet, Inc., initiated 2023-11-02. It names one FDA 510(k) clearance: K200112. Product: Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01. Reason: 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.
Classification: Class II
Status: Ongoing
Initiated: 2023-11-02
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K200112 — Zimmer Hip Joint ReplacementZimmer GmbH·cleared 2020-04-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.