Recall Z-0094-2015— Zimmer, Inc.

Name: FDA recall Z-0094-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-01

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2014-10-01, terminated 2015-03-02. It names one FDA 510(k) clearance: K091508. Product: Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip, Semi-Constrained, Metal/Polymer. Reason: The affected products are missing polar boss threads..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-10-01
Terminated: 2015-03-02
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K091508 — ZIMMER CONTINUUM ACETABULAR SYSTEM, ZIMMER TRILOGY IT ACETABULAR SYSTEMZimmer, Inc.·cleared 2009-09-11

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

Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip, Semi-Constrained, Metal/Polymer

Reason for recall

The affected products are missing polar boss threads.

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