FDA Device recall Z-0117-2021
AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical should…
- FDA Device
- Class II
- terminated
- Published 2020-10-28
On 2020-10-28 the FDA classified a Class II recall of AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical should… by Encore Medical, citing product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0117-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-08-31 |
| Published | 2020-10-28 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Encore Medical |
| Distribution | US |
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
Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.
Identifiers
| code_info | Lot Number: 964W1000 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0117-2021%22
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