DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric… — Class II medical device recall Z-0834-2018
Terminated recall by DePuy Orthopaedics, Inc., reported 2018-03-07. The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a sur
| Recall number | Z-0834-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-08-31 |
| Classified | 2018-03-01 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2020-03-12 |
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 for recall
The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0834-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.