| Class 2 Device Recall GLOBAL UNITE Platform Shoulder System |  |
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: LEO-1100-30-000 REV D.pdf.pdf, LEO-1100-40-000 REV D.pdf.pdf, LEO-110030100_REV D.pdf.pdf, LEO-110030110_REV D.pdf.pdf, LEO-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
|
|
|
|