FDA Device recall Z-0131-2016
AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless application with addition of s…
- FDA Device
- Class II
- terminated
- Published 2015-10-28
On 2015-10-28 the FDA classified a Class II recall of AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless application with addition of s… by Encore Medical, citing difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0131-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-15 |
| Published | 2015-10-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Encore Medical |
| Distribution | CA, FL, ID, PA |
Product
AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless application with addition of screws for fixation. The humeral stem is intended for cemented or cementless use. This device may also be indicated in the salvage of previously failed surgical attempts. Shoulder reconstructive surgery should be reserved for patients who have failed non-operative treatments.
Reason
Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw.
Identifiers
| code_info | Lot: 180052L01 |
|---|
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-0131-2016%22
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