Z-0281-2024Class II

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

Name: Z-0281-2024 RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder...
Creator: Encore Medical, LP
Published: 2023-09-25
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2023-09-25 / Open, Classified / root cause: labeling and UDI

FDA source

Encore Medical, LP began a recall of RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component on 2023-09-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0281-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-25
Posted: 2023-11-08
Recalling firm: Encore Medical, LP
Product: RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On 09/25/23, recall notices were emailed to Agents who were asked to do the following: 1) Pass the notice to all those within your organization or to any organization where the potentially affected product has been transferred. 2) Return all affected devices using the RMA number. 3) Complete and return the response form. Questions can be directed to [email protected]
Quantity in commerce: 20
Distribution: US: MN, TX, IN, OH, SC, RI, ME, NJ, NY, KS, LA, FL, CA
Product codes and lots: UDI-DI: 00190446257585, Lot: 954W1194

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0281-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0281-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-08
Z-0282-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-08

Product code KWS

K172351Class IIAltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket InsertEncore Medical L.P. / cleared 2017-10-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)