Z-1012-2018 Class II Terminated
FDA device recall Z-1012-2018 was initiated by DePuy Orthopaedics, Inc. on November 28, 2017 and is designated Class II. 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 surgi… The recall status is terminated (terminated March 27, 2020). Affected quantity: 85.
Recall Details
- Product Type
- Devices
- Report Date
- March 21, 2018
- Initiation Date
- November 28, 2017
- Termination Date
- March 27, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 85
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.
Distribution Pattern
Distribution Level: The device removal is extended to the companies US Distributors/Sales Offices and Medical Facilities that may have used, purchased, or received the affected devices. Approximately 53 units distributed to firm's international affiliates.
Code Information
Lot # 8556802, 8556803, 8556804, 8556805, 8583381, 8556910, 8556951, 8605849, 8564487, 8572431, 8610357, 8527674.