Recall Z-2375-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-2375-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-30

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-05-30, terminated 2020-05-28. It names one FDA 510(k) clearance: K063251. Product: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 9; 00-7713-009-00. 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..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-05-30
Terminated: 2020-05-28
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K063251 — ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGYZimmer, Inc.·cleared 2007-01-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 9; 00-7713-009-00

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.