Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foi
Summary
The FDA issued a Class II for Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number by Biomet, Inc.. Reason: Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process..
Details
Source
Device Recall
External ID
Z-1607-2024
Action Date
2024-05-01
Status
Ongoing
Category
device
Product Description
Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed into a PETG tray and sealed with Tyvek lid stock (outer barrier). The sealed double barrier system is placed into a paperboard carton with an IFU and label/indicator dots applied to the carton.
Lot/Code Info: Item Number: 189082; Lot Number: 65966530; UDI-DI: (01)00880304436954(17)280413(10)65966530;
Quantity Affected: 19 units (1 US, 18 OUS)
Reason for Recall
Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
Distribution
Worldwide distribution - US Nationwide in the state of IN and the countries of Canada, India, Netherlands, and P.R. China.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-13
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 203 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-1607-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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