Z-2371-2018 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
- 182
Product Description
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 17.5; 00-7713-017-00
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
11016141 60936173 60964158 61086272 62059106 62361479 62521429 62659329 62694085 62745241 62782081 63063354 63063356 63063357 63063358 77004218 77004219 61991590R