PlainRecalls
FDA Devices Moderate Class II Terminated

Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESIS¿, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. 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.

Reported: July 16, 2014 Initiated: May 23, 2014 #Z-2035-2014

Product Description

Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESIS¿, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. 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.

Reason for Recall

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

Details

Recalling Firm
Zimmer, Inc.
Units Affected
315 units
Distribution
Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, China, Europe, India, Japan, Korea and Singapore.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESIS¿, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. 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.. Recalled by Zimmer, Inc.. Units affected: 315 units.
Why was this product recalled?
Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 16, 2014. Severity: Moderate. Recall number: Z-2035-2014.