RSP Glenoid Baseplate, 30mm P2 Porous Coated REF… recallZ-0532-2024 · Encore Medical, LP · initiated Sep 6, 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

Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver

FDA root cause category: Component design/selection

What the company is doing

On 9/6/2023, the firm sent an email, "SE190 URGENT PLEASE READ-QUARANTINE NOTICE" stating that "identified a potential issue" with the RSP BASEPLATE, 30MM, W/P2 COATING". This email instructed customers to "Please reply all to this email when you've located the part(s) and have it quarantined. We will provide further instruction as soon as possible. Please do not request an RMA at this time". On 11/10/2023, the firm sent via email an "URGENT MEDICAL DEVICE RECALL" Letter to customers informing them that the RSP Glenoid Baseplate was found to have an undersized hex, preventing engagement with the Straight Mod Hexdriver and /or Hex Head Screw Driver. Customers were instructed to: 1. Pass this notice to all those within their organization or to any organization where the potentially affected product has been transferred. 2. Review their 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. The customer will be provided with a shipping label to return the affected product. For questions, contact Livia Kuruvila at (914)450-3931 or by email at [email protected]

Recall details

Recall number: Z-0532-2024
Status: Open, Classified
Initiated by the company: Sep 6, 2023
Posted by the FDA: Dec 12, 2023
Recalling firm: Encore Medical, LP
Quantity: 146 units
Product code: PHX
FDA submissions: K112069
Distribution: U.S.: AZ, CA, FL, IN, KS, KY, ME, MN, MS, NJ, OH, Puerto Rico, RI, SC, TN, TX, VA, and WA O.U.S.: None

Product description

RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.

Code information (models, lots, serial numbers)

Part Number: 508-32-204 UDI-DI Code: 00888912144391 Serial Numbers: 769P2825, 769P2846, 769P2893

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

DJO SURGICAL 508-32-204
Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
1 recall544 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.

How recalls are matched to devices · Editorial policy · Report an error on this page