RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained… recallZ-0281-2024 · Encore Medical, LP · initiated Sep 25, 2023
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
Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery.
FDA root cause category: Labeling Change Control
What the company is doing
On 09/25/23, recall notices were emailed to Agents who were asked to do the following: 1) Pass the notice to all those within your organization or to any organization where the potentially affected product has been transferred. 2) Return all affected devices using the RMA number. 3) Complete and return the response form. Questions can be directed to [email protected]
Recall details
- Recall number
- Z-0281-2024
- Status
- Open, Classified
- Initiated by the company
- Sep 25, 2023
- Posted by the FDA
- Nov 8, 2023
- Recalling firm
- Encore Medical, LP
- Quantity
- 20
- Product code
- KWS
- FDA submissions
- K172351
- Distribution
- US: MN, TX, IN, OH, SC, RI, ME, NJ, NY, KS, LA, FL, CA
Product description
RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.
Code information (models, lots, serial numbers)
UDI-DI: 00190446257585, Lot: 954W1194
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DJO SURGICAL 509-03-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall71 reports
Other devices under the same FDA submission
38 devices cleared under K172351 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DJO SURGICAL 509-02-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration108 reports
- DJO SURGICAL 533-06-108Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall40 reports
- DJO SURGICAL 509-03-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration80 reports
- DJO SURGICAL 533-08-108Encore Medical, L.P. · shoulder prosthesis, reverse configuration59 reports
- DJO SURGICAL 509-02-436Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED54 reports
- DJO SURGICAL 533-10-108Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED50 reports
- DJO SURGICAL 509-03-436Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED37 reports
- DJO SURGICAL 509-03-036Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED35 reports
- DJO SURGICAL 533-12-108Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED28 reports
- DJO SURGICAL 509-02-040Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED16 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 93221).
- Z-0282-2024 · Open, ClassifiedRSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
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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