CLASS II Device recall · Reported 10 Jan 2024 · FDA Enforcement Report

Reverse Shoulder System e+ recalled by Encore Medical

Encore Medical is recalling Reverse Shoulder System e+, distributed nationwide in the US. The recall was initiated on 5 Oct 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: (01)00888912144612/Lot Number(s): 381P1167

Quantity recalled17 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-0625-2024
FDA event ID: 93623
Recalling firm: Encore Medical, Austin, TX
Classification: Class II
Status: Completed
Recall initiated: 5 Oct 2023
FDA classified: 2 Jan 2024
Reported: 10 Jan 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

5 Oct 2023	Recall initiated by company
2 Jan 2024	Classified by FDA	+89 days
10 Jan 2024	Published 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

Mislabeling

Product as listed by the FDA

Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797

Where it was distributed

US Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA, AL, FL, CA.

Nationwide Alabama California Florida Indiana Louisiana Maine Minnesota Rhode Island Tennessee Texas Virginia

Questions about this recall

Is Reverse Shoulder System e+ recalled?

Yes. Encore Medical recalled Reverse Shoulder System e+ on 5 Oct 2023. The recall is Class II and its status is Completed. Recall number Z-0625-2024.

Why was it recalled?

Mislabeling

Which lots are affected?

UDI: (01)00888912144612/Lot Number(s): 381P1167

Where was it sold?

US Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA, AL, 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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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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