FDA-Device2016-03-23Class II
Product 33 consists of all product under product code: JDI and same usage: Item no: 662406515 HGP II ACETABULAR CUP BON 662406520 HGP II ACETABULAR CUP BON 662406525 HGP II ACETABULAR CUP BON 662406530 HGP II ACETABULAR CUP BON 662406535 HGP II ACETABULAR CUP BON 662406540 HGP II ACETABULAR CUP BON 662406550 HGP II ACETABULAR CUP BON 662406560 HGP II ACETABULAR CUP BON For use in total hip arthroplasty
Zimmer Manufacturing B.V.
Hazard
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Sold states
US Nationwide Distribution
Affected count
2236
Manufactured in
Turpeaux Industrial Park Rd 1 km 123.4, Mercedita, PR, United States
Products
Product 33 consists of all product under product code: JDI and same usage: Item no: 662406515 HGP II ACETABULAR CUP BON 662406520 HGP II ACETABULAR CUP BON 662406525 HGP II ACETABULAR CUP BON 662406530 HGP II ACETABULAR CUP BON 662406535 HGP II ACETABULAR CUP BON 662406540 HGP II ACETABULAR CUP BON 662406550 HGP II ACETABULAR CUP BON 662406560 HGP II ACETABULAR CUP BON For use in total hip arthroplasty
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1131-2016Don't want to check this manually?
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