Z-1458-2026Class II

Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD...

Name: Z-1458-2026 Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD...
Creator: Encore Medical, LP
Published: 2026-01-15
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2026-01-15 / Open, Classified / root cause: manufacturing process

FDA source

Encore Medical, LP began a recall of Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432 on 2026-01-15. FDA classified it as Class II and gives the reason as "Knee and Humeral socket implants contain incorrect labeling". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1458-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-15
Posted: 2026-02-24
Recalling firm: Encore Medical, LP
Product: Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: Knee and Humeral socket implants contain incorrect labeling.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On January 16, 2026 Enovis (Encore Medical, L.P.) issued an Urgent: Medical Device Recall Expansion notification via E-Mail. The expansion was conducted to include additional products. The original notice was issued on July 9, 2025 Enovis is asking consignees to take the following actions 1. Review your stock for the products and lot numbers for the items to be returned. 2. Remove any product from stock and quarantine. 3. This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 4. Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 or through your regional email. 5. Return all devices (quantities listed above) using the RMA number and shipping label provided by Customer Service.
Quantity in commerce: 20 implants
Distribution: US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.
Product codes and lots: Lot Code: Lot: 385P1263 GTIN: 00888912144575

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1458-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1458-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-24
Z-1459-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-24
Z-1460-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-24

Product code KWS

K100741Class IIReverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis Humeral Inserts, Model 510-00-006/012Encore Medical L.P. / cleared 2010-08-02

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)