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Zimmer Manufacturing B.V. recalls Product 69 consists of all product under product code: JDI and same usage: Item no: 785301701 VERSYS CEMENTED FEM STE
Recalled March 23, 2016 · FDA recall Z-1167-2016 · 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. · FDA Class II
Units
13
Sold at
US Nationwide Distribution
Description
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.
Product
Product 69 consists of all product under product code: JDI and same usage: Item no: 785301701 VERSYS CEMENTED FEM STEM 785301521 VERSYS CEMENTED FEM STEM 15X140MM X-OFF 785301601 VERSYS CEMENTED FEM STEM 16X145MM For use in total or hemi hip arthroplasty
Manufacturer(s)
Zimmer Manufacturing B.V.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →