Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 6; 00-7713-006-00
Published July 11, 2018 · Recall initiated: May 30, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- Products were distributed solely to Japan.
- Lot
- 62044925 62571340 62831345 62869740 62953032 63068885 63081184 63089967
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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