Recall Z-1838-2014— Biomet, Inc.

Name: FDA recall Z-1838-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-07

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2014-05-07, terminated 2015-10-30. It names one FDA 510(k) clearance: K121874. Product: G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.. Reason: Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-05-07
Terminated: 2015-10-30
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K121874 — G7 ACETABULAR SYSTEMBiomet Manufacturing Corp·cleared 2012-11-23

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 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.

Reason for recall

Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery.

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