Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300
Summary
The FDA issued a Class II for Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item N by Biomet, Inc.. Reason: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical int.
Details
Source
Device Recall
External ID
Z-2259-2021
Action Date
2021-08-18
Status
Terminated
Category
device
Product Description
Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300
Lot/Code Info: Lot Numbers/UDI : 626440 (01)00880304474611(17)310409(10)626440 626450 (01)00880304474611(17)310322(10)626450 626460 (01)00880304474611(17)310402(10)626460 626890 (01)00880304474611(17)310323(10)626890 678370 (01)00880304474611(17)310419(10)678370 678770 (01)00880304474611(17)310419(10)678770 678800 (01)00880304474611(17)310409(10)678800 695830 (01)00880304474611(17)310412(10)695830
Quantity Affected: 88 units
Reason for Recall
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-02
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 183 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-2259-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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