FDA recall Z-0833-2018

Product

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.

Distribution

Nationally

Key facts

Status

Terminated

Initiation date

2017-08-31

Report date

2018-03-07

Termination date

2020-03-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0833-2018