PlainRecalls
FDA Devices Moderate Class II Terminated

Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 12.5; 00-7713-012-00

Reported: July 11, 2018 Initiated: May 30, 2018 #Z-2367-2018

Product Description

Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 12.5; 00-7713-012-00

Reason for Recall

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.

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
84
Distribution
Products were distributed solely to Japan.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled? ▼
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 12.5; 00-7713-012-00. Recalled by Zimmer Biomet, Inc.. Units affected: 84.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 11, 2018. Severity: Moderate. Recall number: Z-2367-2018.

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