AltiVate Humeral Socket Shell Trial — Class II medical device recall Z-0131-2016
Terminated recall by Encore Medical, Lp, reported 2015-10-28, distributed in CA, FL, ID, PA. Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw.
| Recall number | Z-0131-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, Lp, Austin, TX, United States |
| Recall initiated | 2015-09-15 |
| Classified | 2015-10-16 |
| Reported by FDA | 2015-10-28 |
| Terminated | 2017-01-10 |
| Distributed | CA, FL, ID, PA |
| Quantity | 20 units |
| Lot numbers | 180052L01 |
| Model numbers | 804-06-052 |
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 for recall
Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw.
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-0131-2016. 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.