FDA Device recall Z-3022-2020
RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440
- FDA Device
- Class II
- ongoing
- Published 2020-10-07
On 2020-10-07 the FDA classified a Class II recall of RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440 by Encore Medical, citing product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3022-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-08-07 |
| Published | 2020-10-07 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Encore Medical |
| Distribution | CA, FL, GA, IN, KS, MN, NY, OK, PA, RI, VA, WA |
Product
RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440
Reason
Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; significant physical impairment, discomfort and/or disruption of treatment of underlying condition; and the patient experiencing dislocation resulting in revision surgery.
Identifiers
| code_info | Part 509-00-440, Lot Numbers 387P1042A and 387P1045A, UDI: 00888912144599 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3022-2020%22
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