Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2361-2018)

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 Plasma Sprayed, Size 4 Extended Offset, 00-7711-004-40

Product Classification:

Class II

Date Initiated: May 30, 2018

Date Posted: July 11, 2018

Recall Number: Z-2361-2018

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: 280

Code Information:

61967700 62386066 62386068 62410987 62416627 62445412 62450669 62458974 62472166 62484291 62503192 62515309 62594187 62601210 62615697 62622678 62636747 62665742 62681670 62740032 62797379 62797380 62882393 62917816 62114291R 77003795R

Distribution Pattern:

Products were distributed solely to Japan.

Voluntary or Mandated:

Voluntary: Firm initiated