CLASS II ONGOING Device recall · Reported 15 Nov 2023 · FDA Enforcement Report

RSP Humeral Small Socket Insert Size Semi-Constrained +4, e-plus recalled

Encore Medical is recalling RSP Humeral Small Socket Insert Size Semi-Constrained +4, e-plus, distributed in 13 states. The recall was initiated on 25 Sep 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 00190446257585, Lot: 954W1194

Quantity recalled20

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-0281-2024
FDA event ID: 93221
Recalling firm: Encore Medical, Austin, TX
Classification: Class II
Status: Ongoing
Recall initiated: 25 Sep 2023
FDA classified: 8 Nov 2023
Reported: 15 Nov 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Hip & Knee Implants

Timeline

25 Sep 2023	Recall initiated by company
8 Nov 2023	Classified by FDA	+44 days
15 Nov 2023	Published in enforcement report	+7 days

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

Reason for recall

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.

Where it was distributed

US: MN, TX, IN, OH, SC, RI, ME, NJ, NY, KS, LA, FL, CA

California Florida Indiana Kansas Louisiana Maine Minnesota New Jersey New York Ohio Rhode Island South Carolina Texas

Questions about this recall

Why was it 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.

Which lots are affected?

UDI-DI: 00190446257585, Lot: 954W1194

Where was it sold?

US: MN, TX, IN, OH, SC, RI, ME, NJ, NY, KS, LA, FL, CA

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.

Other products in this recall event

1 other product · FDA event 93221

This product is part of a recall event; the main page for the event is RSP Humeral Socket Insert Size Semi-Constrained + recalled.

Reported	Class	Recall	Company	Reason	Where
15 Nov 2023	CLASS II	RSP Humeral Socket Insert Size Semi-Constrained + recalled	Encore Medical	Packaging Defects	13 states

More recalls from Encore Medical

All 99

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Device	CLASS II	Empowr 3d Knee Ins, Ve recalled by Encore Medical	Encore Medical	Packaging Defects	14 states
15 Jul 2026Device	CLASS II	Empowr 3d Knee Ins, Ve recalled by Encore Medical	Encore Medical	Packaging Defects	14 states
4 Mar 2026Device	CLASS II	Empowr 3d Knee Ins, Ve recalled by Encore Medical	Encore Medical	Labeling Errors	Nationwide
4 Mar 2026Device	CLASS II	Reverse Shoulder Prosthesis recalled by Encore Medical	Encore Medical	Labeling Errors	Nationwide
4 Mar 2026Device	CLASS II	Reverse Shoulder Prosthesis recalled by Encore Medical	Encore Medical	Labeling Errors	Nationwide

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All 3,110

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30 Sep 2026Device	CLASS II	Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled	New York Embroidery Studio	Packaging Defects	Nationwide
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