CLASS II ONGOING Device recall · Reported 20 Dec 2023 · FDA Enforcement Report

RSP Glenoid Baseplate P2 Porous Coated recalled by Encore Medical

Encore Medical is recalling RSP Glenoid Baseplate P2 Porous Coated, distributed in 18 states. The recall was initiated on 6 Sep 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number: 508-32-204 UDI-DI Code: 00888912144391 Serial Numbers: 769P2825, 769P2846, 769P2893
Quantity recalled146 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-0532-2024
FDA event ID
93428
Recalling firm
Encore Medical, Austin, TX
Classification
Class II
Status
Ongoing
Recall initiated
6 Sep 2023
FDA classified
12 Dec 2023
Reported
20 Dec 2023
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

6 Sep 2023Recall initiated by company
12 Dec 2023Classified by FDA+97 days
20 Dec 2023Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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

ArizonaCaliforniaFloridaIndianaKansasKentuckyMaineMinnesotaMississippiNew JerseyOhioPuerto RicoRhode IslandSouth CarolinaTennesseeTexasVirginiaWashington

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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