Z-2375-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 11, 2018
- Initiation Date
- May 30, 2018
- Termination Date
- May 28, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 116
Product Description
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 9; 00-7713-009-00
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.
Distribution Pattern
Products were distributed solely to Japan.
Code Information
62350575 62647167 62787292 63044896 63044897 63068905 63076554 63120523 63161387 63174034