Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
USBrand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
Recalling Firm: Encore Medical, LP
Reason for Recall / Hazard
Knee and Humeral socket implants contain incorrect labeling.
Product Description & Identification
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
Affected Products
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
Additional Source Details
| Field | Value |
|---|---|
| City | Austin |
| State | TX |
| Event id | 98340 |
| Address 1 | 9800 Metric Blvd |
| Address 2 | N/A |
| Code info | Lot Code: Lot: 378P1382 GTIN: 00888912144544 |
| Postal code | 78758-5445 |
| Report date | 20260304 |
| Product type | Devices |
| Product quantity | 20 implants |
| Reason for recall | Knee and Humeral socket implants contain incorrect labeling. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260115 |
| Initial firm notification | Letter |
| Center classification date | 20260224 |
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Overview
- Recalling FirmEncore Medical, LP
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.
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🚨 SAFETY ALERT: Encore Medical, LP - Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036 Check if your household is affected: https://therecallfile.com/recalls/brand-name-reverse-shoulder-prosthesis-rsp-product-name-rsp-standard-h/FDA-Z-1460-2026
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