AltiVate Reverse Humeral Broach — Class II medical device recall Z-0626-2016
Terminated recall by Encore Medical, Lp, reported 2016-01-20, distributed nationwide. The trial shell mating feature on the broach is undersized.
| Recall number | Z-0626-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, Lp, Austin, TX, United States |
| Recall initiated | 2015-12-08 |
| Classified | 2016-01-09 |
| Reported by FDA | 2016-01-20 |
| Terminated | 2016-03-01 |
| Distributed | Nationwide (US) |
| Quantity | 23 units |
| Model numbers | 804-06-040, 804-06-044, 804-06-046 |
Product
AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for use with Encore Shoulder prosthesis.
Reason for recall
The trial shell mating feature on the broach is undersized.
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-0626-2016. 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.