DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants 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-0834-2018
Product Description
DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants 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
- Quantities co-mingled under initial product
- Distribution
- Nationally
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants 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: Quantities co-mingled under initial product.
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-0834-2018.
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