Device product
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 17.5; 00-7713-017-00
Z-2371-2018
Product summary
- Event
- Event 80188
- Status
- Terminated
- Classification
- Class II
- Quantity
- 182
- Official record key
device-enforcement:Z-2371-2018
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: 11016141 60936173 60964158 61086272 62059106 62361479 62521429 62659329 62694085 62745241 62782081 63063354 63063356 63063357 63063358 77004218 77004219 61991590R
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.