Recall Z-0626-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-0626-2018
Creator: U.S. Food and Drug Administration
Published: 2017-08-25

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-08-25, terminated 2018-08-16. It names one FDA 510(k) clearance: K150552. Product: G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be replaced with artificial prosthesis. The result of the procedure is to relieve pain and restore a sense of normal function and mobility to the damaged joint.. Reason: The affected products are labeled and etched as F-44 mm liners; however, the physical products could potentially be E-42 mm liners..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-08-25
Terminated: 2018-08-16
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K150552 — ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.·cleared 2015-06-04

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

G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be replaced with artificial prosthesis. The result of the procedure is to relieve pain and restore a sense of normal function and mobility to the damaged joint.

Reason for recall

The affected products are labeled and etched as F-44 mm liners; however, the physical products could potentially be E-42 mm liners.

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