Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01
Summary
The FDA issued a Class II for Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01 by Biomet, Inc.. 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 pro.
Details
Source
Device Recall
External ID
Z-0569-2024
Action Date
2023-12-27
Status
Ongoing
Category
device
Product Description
Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01
Lot/Code Info: UDI-DI: 00889024430556; Lot Number: 3145299
Quantity Affected: 10 units
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.
Distribution
US States: AL, CA, MD, MI, NC, OH, OK, TN, TX. Netherlands.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-02
Company
Warsaw, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 173 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Biomet, Inc. has 66 FDA actions in our database, including 60 recalls and 6 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Biomet, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Biomet, Inc. have FDA actions?
Biomet, Inc. has 66 FDA actions in our database, including 60 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0569-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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