CLASS II ONGOING Device recall · Reported 4 Mar 2026 · FDA Enforcement Report

Reverse Shoulder Prosthesis recalled by Encore Medical

Encore Medical is recalling Reverse Shoulder Prosthesis (Rsp) Rsp Humeral Socket Insert +, Standard HXe-plus, distributed nationwide in the US. The recall was initiated on 15 Jan 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: Lot: 385P1263 GTIN: 00888912144575

Quantity recalled20 implants

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-1458-2026
FDA event ID: 98340
Recalling firm: Encore Medical, Austin, TX
Classification: Class II
Status: Ongoing
Recall initiated: 15 Jan 2026
FDA classified: 24 Feb 2026
Reported: 4 Mar 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

15 Jan 2026	Recall initiated by company
24 Feb 2026	Classified by FDA	+40 days
4 Mar 2026	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

Knee and Humeral socket implants contain incorrect labeling.

Product as listed by the FDA

Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432

Where it was distributed

US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.

Nationwide California Colorado Florida Illinois Indiana Louisiana Massachusetts Michigan Missouri Montana New Jersey Oklahoma Pennsylvania Rhode Island Tennessee Virginia Wyoming

Questions about this recall

Why was it recalled?

Knee and Humeral socket implants contain incorrect labeling.

Which lots are affected?

Lot Code: Lot: 385P1263 GTIN: 00888912144575

Where was it sold?

US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, 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

2 other products · FDA event 98340

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

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
11 Feb 2026Device	CLASS II	Empowr Acetabular System: Liner, 10 degree Hooded, HXe+, 36H recalled	Encore Medical	Packaging Defects	14 states

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