Zimmer Manufacturing B.V. recalls Product 11 consists of all product under product code JDI , and same usage: Item no: 902602500 6 DEGREE COCR FEM HEAD 2…

Recall date

January 11, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1109-2016

FDA classification

Class II

Brand / firm

Zimmer Manufacturing B.V.

Sold / distributed

US Nationwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Product 11 consists of all product under product code JDI , and same usage: Item no: 902602500 6 DEGREE COCR FEM HEAD 26 902602600 6 DEGREE COCR FEM HEAD 26 902602700 6 DEGREE COCR FEM HEAD 26 902602800 6 DEGREE COCR FEM HEAD 28 902602900 6 DEGREE COCR FEM HEAD 28 902603000 6 DEGREE COCR FEM HEAD 28 902603300 6 DEGREE COCR FEM HEAD 32 902603200 6 DEGREE COCR FEM HEAD 32 Product Usage: For use in total or hemi hip arthroplasty