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U.S. Department of Health and Human Services

Class 2 Device Recall GLOBAL UNITE Platform Shoulder System

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  Class 2 Device Recall GLOBAL UNITE Platform Shoulder System see related information
Date Initiated by Firm November 28, 2017
Date Posted February 27, 2018
Recall Status1 Terminated 3 on March 27, 2020
Recall Number Z-1012-2018
Recall Event ID 79257
510(K)Number K133834  
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
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
Code Information Lot # 8556802, 8556803, 8556804, 8556805, 8583381, 8556910, 8556951, 8605849, 8564487, 8572431, 8610357, 8527674.
Recalling Firm/
Manufacturer		 DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact Mindy K. Tinsley
574-371-7179
Manufacturer 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.
FDA Determined
Cause 2		 Employee error
Action DePuy Orthopaedics, Inc. is voluntarily recalling 11 lots of the GLOBAL¿ UNITE¿ Platform Shoulder System. The device is being recalled because 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. Once the screw is properly assembled, there is no additional risk to the patient. Further distribution or use of the affected lots is to cease immediately.DePuy Orthopaedics, Inc. is not recommending prophylactic revision. The company recommends that surgeons discuss potential clinical implications and risks with symptomatic patients that received the affected lots and may have experienced a surgical delay. Please take the following actions: Please cease using the affected components immediately. Return affected devices: Medical facilities are to determine if any of the recalled devices are still on hand, and return affected devices immediately to their DePuy Synthes Sales Consultant or return them to DePuy Synthes Joint Reconstruction for credit following normal procedures. Reconciliation forms should be faxed to 574-371-4939. Note: The affected lots may be on consignment at your facility. Reconciliation Form: Complete the Reconciliation Form and return to your DePuy Synthes Sales Consultant, email to DPYUS-JointReconFieldActions@its.jnj.com, or fax to 574-371-4939 within five (5) days of this notice. Records: Retain a copy of the completed Reconciliation Form in your files along with this notice. Additional Notifications: Notify surgeons at your facility by providing them with a copy of this notice to ensure surgeons are aware of this recall. Forward this notice to others in your facility that need to be informed.If any affected product has been forwarded to another facility, contact that facility immediately to communicate this field action with the facility/facilities. Maintain a copy of this notice wi
Quantity in Commerce 85
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KWS and Original Applicant = DEPUY (IRELAND)
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