Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-301301
Summary
The FDA issued a Class II for Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A by Biomet, Inc.. Reason: The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not.
Details
Source
Device Recall
External ID
Z-0670-2022
Action Date
2022-03-02
Status
Terminated
Category
device
Product Description
Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-301301
Lot/Code Info: Lot Number: 853650, 853810 UDI: (01)00880304468030(17) 290122(10)853650; (01)00880304468030(17) 290211(10)853810
Quantity Affected: 19 units
Reason for Recall
The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Ecuador, Netherlands.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-07
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 122 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-0670-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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