CLASS II ONGOING Device recall · Reported 18 Oct 2023 · FDA Enforcement Report

Reverse Prosthesis Shoulder System, Screw, Locking Bone recalled

Encore Medical is recalling Reverse Prosthesis Shoulder System, Screw, Locking Bone, Rsp, 5mmX30mm long, distributed in 14 states. The recall was initiated on 22 Aug 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 00888912024570, Lot: 835C2074, EXP: 2029-03-9

Quantity recalled70

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-0098-2024
FDA event ID: 93080
Recalling firm: Encore Medical, Austin, TX
Classification: Class II
Status: Ongoing
Recall initiated: 22 Aug 2023
FDA classified: 12 Oct 2023
Reported: 18 Oct 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

22 Aug 2023	Recall initiated by company
12 Oct 2023	Classified by FDA	+51 days
18 Oct 2023	Published in enforcement report	+6 days

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

Reason for recall

Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation.

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

REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130

Where it was distributed

US: FL, IN, WI, IA, MN, KY, NY, AZ, RI, WA, OH, SC, VA, TX. OUS: MX

Arizona Florida Iowa Indiana Kentucky Minnesota New York Ohio Rhode Island South Carolina Texas Virginia Washington Wisconsin

Stores named: Walmart

Questions about this recall

Is Reverse Prosthesis Shoulder System, Screw, Locking Bone, Rsp, 5mmX30mm long recalled?

Yes. Encore Medical recalled Reverse Prosthesis Shoulder System, Screw, Locking Bone, Rsp, 5mmX30mm long on 22 Aug 2023. The recall is Class II and its status is Ongoing. Recall number Z-0098-2024.

Why was it recalled?

Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation.

Which lots are affected?

UDI-DI: 00888912024570, Lot: 835C2074, EXP: 2029-03-9

Where was it sold?

US: FL, IN, WI, IA, MN, KY, NY, AZ, RI, WA, OH, SC, VA, TX. OUS: MX

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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