Z-2368-2018 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
- 510
Product Description
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 13.5; 00-7713-013-00
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
61349197 61690629 61721526 61781828 62010553 62118873 62130040 62201735 62258067 62275219 62356222 62361475 62484285 62496087 62546976 62559966 62578405 62616562 62634733 62652960 62700955 62733912 62798024 62808130 62808133 62869767 62869769 62953079 62993667 62993703 63034232 63038804 63044938 63068954 63068955 63068957 63076577 63081279 63094534 63094538 63102051 63128592 63128593 62521418R 62939011R 63128592R 77002646R