DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.
Reported: March 7, 2018 Initiated: August 31, 2017 #Z-0833-2018
Product Description
DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.
Reason for Recall
The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay.
Details
- Recalling Firm
- DePuy Orthopaedics, Inc.
- Units Affected
- 23,053 units
- Distribution
- Nationally
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.. Recalled by DePuy Orthopaedics, Inc.. Units affected: 23,053 units.
Why was this product recalled? ▼
The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 7, 2018. Severity: Moderate. Recall number: Z-0833-2018.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11