FDA-Device2022-03-02Class II
Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-301301
Biomet, Inc.
Hazard
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.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Ecuador, Netherlands.
Affected count
19 units
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-301301
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0670-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief