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Lower risk Medical device recall · FDA · Published November 28, 2017

DePuy GLOBAL UNITE Shoulder System Recall: Screw Inversion Risk

DePuy recalls specific lots of GLOBAL UNITE Platform Shoulder System due to screw inversion during assembly, potentially causing surgical delays. Affected patients should contact DePuy for guidance.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1012-2018Medical deviceDePuy ›
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Contact the company

Recalling firmDePuy Orthopaedics, Inc.700 Orthopaedic Dr · Warsaw, IN 46582-3994
✎ GovInfoNow plain-language explainer

DePuy is recalling specific lots of the GLOBAL UNITE Platform Shoulder System because screws can become inverted during assembly, which may cause surgical delays. This affects patients who have received the recalled implants. Read more at govinfonow.com/recall/72473-depuy-global-unite-shoulder-system-recall-screw-inversion-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/72473-depuy-global-unite-shoulder-system-recall-screw-inversion-risk · Updated September 14, 2026 · FDA enforcement record: FDA #Z-1012-2018

Cite this page

“DePuy GLOBAL UNITE Shoulder System Recall: Screw Inversion Risk.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72473-depuy-global-unite-shoulder-system-recall-screw-inversion-risk. Based on FDA recall #Z-1012-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1012-2018%22&limit=1).

The FDA announced on 2017-11-28 that DePuy Orthopaedics, Inc. is recalling specific lots of the GLOBAL UNITE Platform Shoulder System due to inverted screws that may cause surgical delays. The agency classified the Class II recall as voluntary.

How to tell if you have it

  • Brand: DePuy
  • Product: GLOBAL UNITE Anatomic Body and GLOBAL UNITE Fracture Body
  • Lot codes: 8556802, 8556803, 8556804, 8556805, 8583381, 8556910, 8556951, 8605849, 8564487, 8572431, 8610357, 8527674

The hazard

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

Context

GovInfoNow's records show DePuy Orthopaedics, Inc. has had 23 other recalls on record since 2017-07-12. Other recent recalls of similar products include ATTUNE Knee Component Recall (2024-03-12), Attune Revision Limb Preservation Tibial Insert Recall (2023-02-15), and ATTUNE Sizing Guide Recall (2022-06-29). Other recent recalls of similar products include restor3d Veritas Standard Glenoid Baseplate Recall (2026-06-30), Depuy ATTUNE Revision Hinge Femoral LT SZ 5 CEM Recall (2026-04-03), and U2 Total Knee System PSA Box Trial Recall (2026-05-20).

How to tell if you have this one

Check the lot numbers listed: 8556802, 8556803, 8556804, 8556805, 8583381, 8556910, 8556951, 8605849, 8564487, 8572431, 8610357, 8527674. The product is used in shoulder replacement procedures.

  • Brand
    DePuy
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Contact DePuy

    Reach out to DePuy Orthopaedics for guidance on next steps regarding the recalled implant.

How this recall unfolded

Recall timeline

FDA terminated this recall 2.3 years after the firm started it.

1. Firm started the recall: Nov 28, 201712. FDA classified it Class II: Mar 14, 201823. Published in FDA’s Enforcement Report: Mar 21, 201834. FDA terminated the recall: Mar 27, 2020420172020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1012-2018 (November 28, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1012-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA