AltiVate Reverse Small Socket Insert — Class II medical device recall Z-0117-2021
Terminated recall by Encore Medical, LP, reported 2020-10-28, distributed nationwide. Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.
| Recall number | Z-0117-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, LP, Austin, TX, United States |
| Recall initiated | 2020-08-31 |
| Classified | 2020-10-16 |
| Reported by FDA | 2020-10-28 |
| Terminated | 2024-04-19 |
| Distributed | Nationwide (US) |
| Quantity | 15 |
| Reason classes | labeling |
| Lot numbers | 964W1000 |
| Model numbers | 509-03-044 |
Product
AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use.
Reason for recall
Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.
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-0117-2021. 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.