Zimmer Manufacturing B.V. recalls Product 69 consists of all product under product code: JDI and same usage: Item no: 785301701 VERSYS CEMENTED FEM STEM…

Recall date

January 11, 2016

Source

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

Recall number

Z-1167-2016

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 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