FDA Device recall Z-0098-2024
REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
- FDA Device
- Class II
- ongoing
- Published 2023-10-18
On 2023-10-18 the FDA classified a Class II recall of REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130 by Encore Medical, citing reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequat….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0098-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-22 |
| Published | 2023-10-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Encore Medical |
| Distribution | AZ, FL, IA, IN, KY, MN, NY, OH, RI, SC, TX, VA, WA, WI |
Product
REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
Reason
Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation.
Identifiers
| code_info | UDI-DI: 00888912024570, Lot: 835C2074, EXP: 2029-03-9 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Encore Medical
- Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee…
FDA Device · Class II · 2026-07-15 · Encore Medical - Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee…
FDA Device · Class II · 2026-07-15 · Encore Medical - Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 5…
FDA Device · Class II · 2026-03-04 · Encore Medical - Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00…
FDA Device · Class II · 2026-03-04 · Encore Medical - Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
FDA Device · Class II · 2026-03-04 · Encore Medical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0098-2024%22
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