Reverse Shoulder System e+, REF 509-01-032, RSP Humeral… recallZ-0625-2024 · Encore Medical, LP · initiated Oct 5, 2023
Completed
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
Mislabeling
FDA root cause category: Packaging process control
What the company is doing
On October 5, 2022, DJO Global (Enovis company) issued a "Urgent Medical Device Recall" Notification via E-Mail. DJO asked consignees to take the following actions: 1. This notice needs to be passed on to all those within your organization or to any organization where the potentially affected product has been transferred. 2. Review your stock for the affected products and lot numbers for the items to be returned. 3. Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 to place a replacement order and receive an RMA number. You will be provided with a shipping label to return the affected product. 4. Return all affected devices (quantities listed above) using the RMA number. Report any adverse events related to this issue to Customer Service. Additionally, adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Recall details
- Recall number
- Z-0625-2024
- Status
- Completed
- Initiated by the company
- Oct 5, 2023
- Posted by the FDA
- Jan 2, 2024
- Recalling firm
- Encore Medical, LP
- Quantity
- 17 units
- Product code
- PHX
- FDA submissions
- K051075
- Distribution
- US Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA, AL, FL, CA.
Product description
Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
Code information (models, lots, serial numbers)
UDI: (01)00888912144612/Lot Number(s): 381P1167
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DJO SURGICAL 509-01-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall52 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 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 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 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 93623).
- Z-0626-2024 · CompletedREF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2
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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