M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number
Summary
The FDA issued a Class II for M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Numb by Zimmer, Inc.. Reason: The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa..
Details
Source
Device Recall
External ID
Z-2519-2023
Action Date
2023-09-13
Status
Ongoing
Category
device
Product Description
M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)
Lot/Code Info: Item Number: 00771100640, UDI-DI: 00889024131699, Lot Number: 65236202; Item Number: 00771100440, UDI-DI: 00889024131613, Lot Number: 65249215
Quantity Affected: 24 units
Reason for Recall
The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.
Distribution
Worldwide - US Nationwide distribution in the states of AL, CA, GA, MI, NJ, PA, TN, and WI. The countries of Brazil, Canada, Netherlands.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-26
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 148 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Zimmer, Inc. has 87 FDA actions in our database, including 65 recalls and 22 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 (Zimmer, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Zimmer, Inc. have FDA actions?
Zimmer, Inc. has 87 FDA actions in our database, including 65 recalls and 22 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2519-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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