Recall Z-0834-2018— DePuy Orthopaedics, Inc.
Class II · Terminated
Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2017-08-31, terminated 2020-03-12. It names one FDA 510(k) clearance: K120174. 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.. Reason: The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay..
- Recalling firm
- DePuy Orthopaedics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-08-31
- Terminated
- 2020-03-12
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.