Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2363-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 5; 00-7713-005-00

Product Classification:

Class II

Date Initiated: May 30, 2018

Date Posted: July 11, 2018

Recall Number: Z-2363-2018

Event ID: 80188

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.

Status: Terminated

Product Quantity: 227

Code Information:

61930610 61967651 62010520 62053333 62430587 62460391 62503140 62794209 62876154 62927048 63034172 63034173 63034174 63038714 63076525 63081182 63128514 63128518 63161307

Distribution Pattern:

Products were distributed solely to Japan.

Voluntary or Mandated:

Voluntary: Firm initiated