Z-2363-2018 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
- 227
Product Description
Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 5; 00-7713-005-00
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
61930610 61967651 62010520 62053333 62430587 62460391 62503140 62794209 62876154 62927048 63034172 63034173 63034174 63038714 63076525 63081182 63128514 63128518 63161307