Recall Z-2483-2015— Biomet, Inc.

Name: FDA recall Z-2483-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-28

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2015-07-28, terminated 2016-05-17. It names one FDA 510(k) clearance: K093235. Product: Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis.. Reason: The device was assembled without screw hole plugs..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-07-28
Terminated: 2016-05-17
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K093235 — RINGLOC + HYBRID ACETABULAR SYSTEMBiomet, Inc.·cleared 2010-04-30

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

Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis.

Reason for recall

The device was assembled without screw hole plugs.

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