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 16.25; 00-7713-016-00

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.

Lot/Code Info: 60936172 61002401 61150834 61326535 61332941 61359861 61375746 61403159 61409715 61459935 61479150 61559581 61729731 61741696 61757673 62014555 62014556 62014557 62059105 62071437 62118877 62130043 62163680 62207789 62282107 62323345 62356227 62420836 62432974 62503175 62521427 62560139 62578410 62586781 62616563 62647184 62659327 62694084 62707654 62721037 62782080 62803651 62927127 62939025 62953083 63063349 63063351 63063352 63068972 63090045 63090046 63090047 63116808 63116809 63116810 77004216 61590535R 62071437R

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