REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE… recallZ-0098-2024 · Encore Medical, LP · initiated Aug 22, 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
Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation.
FDA root cause category: Mixed-up of materials/components
What the company is doing
On 8/22/23, recall notices were emailed to agents and registration holders who were asked to do the following: Contact Customer Service at 1-800-456-8696 to assist with return and replacement. 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. Complete and return the acknowledgement and response form. If you have questions, please email [email protected]
Recall details
- Recall number
- Z-0098-2024
- Status
- Open, Classified
- Initiated by the company
- Aug 22, 2023
- Posted by the FDA
- Oct 12, 2023
- Recalling firm
- Encore Medical, LP
- Quantity
- 70
- Product code
- PHX
- FDA submissions
- K041066
- Distribution
- US: FL, IN, WI, IA, MN, KY, NY, AZ, RI, WA, OH, SC, VA, TX. OUS: MX
Product description
REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
Code information (models, lots, serial numbers)
UDI-DI: 00888912024570, Lot: 835C2074, EXP: 2029-03-9
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DJO SURGICAL 506-03-130Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall5 reports
Other devices under the same FDA submission
13 devices cleared under K041066 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- DJO SURGICAL 508-00-000Encore Medical, L.P. · shoulder prosthesis, reverse configuration21 reports
- DJO SURGICAL 506-00-006Encore Medical, L.P. · shoulder prosthesis, reverse configuration15 reports
- DJO SURGICAL 506-00-008Encore Medical, L.P. · shoulder prosthesis, reverse configuration10 reports
- DJO SURGICAL 507-06-175Encore Medical, L.P. · shoulder prosthesis, reverse configuration6 reports
- DJO SURGICAL 506-03-114Encore Medical, L.P. · shoulder prosthesis, reverse configuration5 reports
- DJO SURGICAL 506-00-007Encore Medical, L.P. · shoulder prosthesis, reverse configuration5 reports
- DJO SURGICAL 506-03-126Encore Medical, L.P. · shoulder prosthesis, reverse configuration4 reports
- DJO SURGICAL 508-00-008Encore Medical, L.P. · shoulder prosthesis, reverse configuration4 reports
- DJO SURGICAL 506-03-118Encore Medical, L.P. · shoulder prosthesis, reverse configuration3 reports
- DJO SURGICAL 508-00-004Encore Medical, L.P. · shoulder prosthesis, reverse configuration3 reports
- DJO SURGICAL 506-03-138Encore Medical, L.P. · shoulder prosthesis, reverse configuration2 reports
- DJO SURGICAL 507-08-175Encore Medical, L.P. · shoulder prosthesis, reverse configuration2 reports
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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