Device product
Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 6; 00-7713-006-00
Z-2364-2018
Product summary
- Event
- Event 80188
- Status
- Terminated
- Classification
- Class II
- Quantity
- 96
- Official record key
device-enforcement:Z-2364-2018
Official wording
Reason: 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.
Code information: 62044925 62571340 62831345 62869740 62953032 63068885 63081184 63089967
Distribution pattern: Products were distributed solely to Japan.
Derived failure modes
-
Unknown
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.