FDA Device recall Z-0281-2024
RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component
- FDA Device
- Class II
- ongoing
- Published 2023-11-15
On 2023-11-15 the FDA classified a Class II recall of RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component by Encore Medical, citing two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in s….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0281-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-25 |
| Published | 2023-11-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Encore Medical |
| Distribution | CA, FL, IN, KS, LA, ME, MN, NJ, NY, OH, RI, SC, TX |
Product
RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.
Reason
Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery.
Identifiers
| code_info | UDI-DI: 00190446257585, Lot: 954W1194 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0281-2024%22
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