Z-1012-2018Class II

The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or...

Name: Z-1012-2018 The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or...
Creator: DePuy Orthopaedics, Inc.
Published: 2017-11-28
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2017-11-28 / Terminated / root cause: manufacturing process

FDA source

DePuy Orthopaedics, Inc. began a recall of The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling... on 2017-11-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1012-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-28
Posted: 2018-02-27
Terminated: 2020-03-27
Recalling firm: Depuy Orthopaedics Inc.
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
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
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.
Root cause tag: manufacturing process
FDA root cause: 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 [email protected], 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.
Product codes and lots: Lot # 8556802, 8556803, 8556804, 8556805, 8583381, 8556910, 8556951, 8605849, 8564487, 8572431, 8610357, 8527674.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1012-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1012-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-14

Product code KWS

K133834Class IIDepuy Global Unite Shoulder SystemDepuy(Ireland) / cleared 2014-04-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)