Brand Name: Reverse Shoulder Prosthesis (RSP) recallZ-1460-2026 · Encore Medical, LP · initiated Jan 15, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Encore Medical, LP or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Knee and Humeral socket implants contain incorrect labeling.
FDA root cause category: Process control
What the company is doing
On January 16, 2026 Enovis (Encore Medical, L.P.) issued an Urgent: Medical Device Recall Expansion notification via E-Mail. The expansion was conducted to include additional products. The original notice was issued on July 9, 2025 Enovis is asking consignees to take the following actions 1. Review your stock for the products and lot numbers for the items to be returned. 2. Remove any product from stock and quarantine. 3. This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 4. Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 or through your regional email. 5. Return all devices (quantities listed above) using the RMA number and shipping label provided by Customer Service.
Recall details
- Recall number
- Z-1460-2026
- Status
- Open, Classified
- Initiated by the company
- Jan 15, 2026
- Posted by the FDA
- Feb 24, 2026
- Recalling firm
- Encore Medical, LP
- Quantity
- 20 implants
- Product code
- PHX
- FDA submissions
- K051075
- 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.
Product description
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
Code information (models, lots, serial numbers)
Lot Code: Lot: 378P1382 GTIN: 00888912144544
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
Other devices under the same FDA submission
27 devices cleared under K051075 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 reports
- DJO SURGICAL 509-01-436Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall62 reports
- DJO SURGICAL 508-40-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration111 reports
- DJO SURGICAL 509-01-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall52 reports
- DJO SURGICAL 508-01-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall40 reports
- DJO SURGICAL 509-01-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration79 reports
- DJO SURGICAL 509-01-432Encore Medical, L.P. · shoulder prosthesis, reverse configuration57 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 98340).
- Z-1458-2026 · Open, ClassifiedBrand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
- Z-1459-2026 · Open, ClassifiedBrand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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