medical Class II Updated 2018-07-11

Zimmer Biomet, Inc. recalls Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology

Recalled Product

Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 15; 00-7713-015-00

Hazard / Issue

M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.

Issued by

FDA

Distribution: Products were distributed solely to Japan.
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