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Recall Observatory FDA recall evidence

Device product

Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02

Z-0570-2024

November 02, 2023

Class II

Product summary

Firm
Biomet, Inc.
Event
Event 93486
Status
Ongoing
Classification
Class II
Quantity
10 units
Official record key
device-enforcement:Z-0570-2024

Official wording

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.

Code information: UDI-DI: 00889024430563; Lot Number: 3145300

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.