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.
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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