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DePuy Orthopaedics, Inc. recalls DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulde
Recalled March 7, 2018 · FDA recall Z-0834-2018 · DePuy Orthopaedics
Hazard
The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay. · FDA Class II
Units
Quantities co-mingled under initial product
Sold at
Nationally
Description
The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay.
Product
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.
Manufacturer(s)
DePuy Orthopaedics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →