Z-0532-2024Class II

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

Name: Z-0532-2024 RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device
Creator: Encore Medical, LP
Published: 2023-09-06
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2023-09-06 / Open, Classified / root cause: design

FDA source

Encore Medical, LP began a recall of RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device on 2023-09-06. FDA classified it as Class II and gives the reason as "Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0532-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-06
Posted: 2023-12-12
Recalling firm: Encore Medical, LP
Product: RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
Product code: PHX Shoulder Prosthesis, Reverse Configuration
Reason for recall: Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver
Root cause tag: design
FDA root cause: Component design/selection
Action: 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]
Quantity in commerce: 146 units
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 codes and lots: Part Number: 508-32-204 UDI-DI Code: 00888912144391 Serial Numbers: 769P2825, 769P2846, 769P2893

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0532-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0532-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-12

Product code PHX

K112069Class IIRsp Glenoid Baseplate Porous CoatedEncore Medical L.P. / cleared 2011-11-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)