Zimmer, Inc. recalls Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.

Recalled July 16, 2014 · FDA recall Z-2033-2014 · Zimmer

Hazard

Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems. · FDA Class II

Units

1487 units

Sold at

Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, China, Europe, India, Japan, Korea and Singapore.

Description

Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.

Product

Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.25, 20.0 & 22.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper implantation of these components.

Manufacturer(s)

Zimmer, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →