DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulde...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0834-2018.
The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0834-2018.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Depuy Orthopaedics, Inc. or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0834-2018.
DePuy Orthopaedics, Inc.
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Depuy Orthopaedics, Inc. Recall FAQ
Depuy Orthopaedics, Inc. is the subject of a medical implants safety report: DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulde.... The notice was published on August 31, 2017 by the U.S. Food and Drug Administration (FDA). Approximately 0 units are potentially affected.