Recall Z-1837-2014— Biomet, Inc.

Name: FDA recall Z-1837-2014
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 Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.. 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 Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.

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.