Encore Medical RSP Humeral Socket Insert Recall: Incorrect Labeling Hazard
Encore Medical recalls RSP Humeral Socket Inserts with incorrect labeling that may cause confusion during surgery. Affected models include 509-00-432 (Lot 385P1263).
Lower-risk recall
Knee and Humeral socket implants contain incorrect labeling.
Contact the company
What happened, in plain English
Encore Medical is recalling specific humeral socket inserts for reverse shoulder prostheses due to incorrect labeling. This could lead to confusion during surgical procedures if the wrong part is used. Read more at govinfonow.com/recall/50152-encore-medical-rsp-humeral-socket-insert-recall-incorrect-labeling-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/50152-encore-medical-rsp-humeral-socket-insert-recall-incorrect-labeling-hazard · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1458-2026
Cite this page
“Encore Medical RSP Humeral Socket Insert Recall: Incorrect Labeling Hazard.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50152-encore-medical-rsp-humeral-socket-insert-recall-incorrect-labeling-hazard. Based on FDA recall #Z-1458-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1458-2026%22&limit=1).
Why it’s dangerous
The implants have incorrect labeling, which could cause confusion during surgery. If the wrong part is used, it might lead to improper implant placement or complications during the procedure.
Who’s affected
Orthopedic surgeons and hospitals using the specific model (50:00-432, Lot 385P1263) for reverse shoulder procedures are most at risk. Patients receiving these implants may be affected if the wrong part is used.
How to tell if you have this one
Check for model number 509-00-432 and lot code 385P1263 on the product. The product is sold under the brand name Reverse Shoulder Prosthesis (RSP).
- Brand
Encore Medical- Product
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1458-2026 | Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432; Lot Code: Lot: 385P1263 GTIN: 00888912144575 | 20 implants |
| Z-1459-2026 | Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707; Lot Code: Lot: 151T1055A GTIN: 00888912167147 | 14 implants |
| Z-1460-2026 | Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036; Lot Code: Lot: 378P1382 GTIN: 00888912144544 | 20 implants |
What to do — step by step
Check Product Labeling
Look for model number 509-00-432 and lot code 385P1263 on the product.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 17 states.
FDA distribution: “US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Colorado, Florida, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Missouri, Montana, New Jersey, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Virginia, Wyoming.
Recall timeline
FDA published this recall 48 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1458-2026 (January 15, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1458-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.