FDA-Device2018-03-07Class II
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.
DePuy Orthopaedics, Inc.
Hazard
The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay.
Sold states
Nationally
Affected count
23,053 units
Manufactured in
700 Orthopaedic Dr, N/A, Warsaw, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0833-2018Don't want to check this manually?
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