FDA Device recall Z-1520-2013
DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty
- FDA Device
- Class II
- terminated
- Published 2013-06-19
On 2013-06-19 the FDA classified a Class II recall of DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty by Depuy Orthopaedics, citing the Glenosphere Orientation Guide Instrument Used with the Delta XTEND Reverse Shoulder is being recalled because an arrow that is etched on the instrument was incorrectly placed….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1520-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-03 |
| Published | 2013-06-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Depuy Orthopaedics |
| Distribution | US |
Product
DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty. The orientation guide is used to properly align the glenosphere.
Reason
The Glenosphere Orientation Guide Instrument Used with the Delta XTEND Reverse Shoulder is being recalled because an arrow that is etched on the instrument was incorrectly placed on the opposite side of the instrument. Using the improperly etched arrow as a guide could potentially lead to incorrect orientation of the glenosphere implant.
Identifiers
| code_info | Part Number 230795000/Lot Number 5120443 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1520-2013%22
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