Recall Z-1012-2018— DePuy Orthopaedics, Inc.

Name: FDA recall Z-1012-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-28

Class II · Terminated

Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2017-11-28, terminated 2020-03-27. It names one FDA 510(k) clearance: K133834. Product: The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LE¿O-1100-30-000 REV D.pdf.pdf, LE¿O-1100-40-000 REV D.pdf.pdf, LE¿O-110030100_REV D.pdf.pdf, LE¿O-110030110_REV D.pdf.pdf, LE¿O-110030120_REV D.pdf.pdf. Reason: The screw in specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE Fracture Body was inverted during assembly to the body, which will cause the humeral stem to sit proud and may cause surgical delays..

Recalling firm: DePuy Orthopaedics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-11-28
Terminated: 2020-03-27
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K133834 — DEPUY GLOBAL UNITE SHOULDER SYSTEMDepuy(Ireland)·cleared 2014-04-03

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

The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LE¿O-1100-30-000 REV D.pdf.pdf, LE¿O-1100-40-000 REV D.pdf.pdf, LE¿O-110030100_REV D.pdf.pdf, LE¿O-110030110_REV D.pdf.pdf, LE¿O-110030120_REV D.pdf.pdf

Reason for recall

The screw in specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE Fracture Body was inverted during assembly to the body, which will cause the humeral stem to sit proud and may cause surgical delays.

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