Summary
The FDA issued a Class II for NexGen Precoat Stemmed Tibial Plate Size 5 by Zimmer, Inc.. Reason: Device outer packaging was incorrectly labeled..
Details
Source
Device Recall
External ID
Z-2092-2023
Action Date
2023-07-12
Status
Terminated
Category
device
Product Description
NexGen Precoat Stemmed Tibial Plate Size 5
Lot/Code Info: Model No. 00598004701; UDI No./Lot. No.: (01)00889024217607(17)321228(10)J7418537/J7418537 and (01)00889024217607(17)321228(10)J7418542/J7418542.
Quantity Affected: N/A
Reason for Recall
Device outer packaging was incorrectly labeled.
Distribution
International distribution in the country of India.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-19
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 287 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-2092-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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