NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01
Summary
The FDA issued a Class II for NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01 by Zimmer, Inc.. Reason: Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statist.
Details
Source
Device Recall
External ID
Z-0466-2023
Action Date
2022-12-21
Status
Ongoing
Category
device
Product Description
NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01
Lot/Code Info: All Unexpired Lots
Quantity Affected: 1673
Reason for Recall
Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used with either the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) components as compared to other total knee arthroplasties in the United Kingdom National Joint Registry (UK NJR). Removing the NexGen Stemmed Option Tibial Component f rom inventory will prevent its future implantation with either the LPS Flex or LPS Flex GSF femoral components and mitigate the increased revision risk with these two specific combinations of tibial and femoral component.
Distribution
Worldwide - US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-06
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 474 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-0466-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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