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Urgent Enforcement Amended Final

Encore Medical Recall: RSP Implant Incorrect Labeling

Favicon for changeflow.com FDA: Device Recalls Class II
Filed March 4th, 2026
Detected March 29th, 2026
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Summary

The FDA has issued a Class II recall for Encore Medical's Reverse Shoulder Prosthesis (RSP) due to incorrect labeling on knee and humeral socket implants. The recall affects nationwide distribution within the US.

What changed

Encore Medical, LP is recalling its Reverse Shoulder Prosthesis (RSP) HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus (Model/Catalog Number: 509-00-432) due to incorrect labeling on knee and humeral socket implants. This recall is classified as Class II, indicating that use of or exposure to a problematic product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The product was distributed nationwide across multiple US states.

Healthcare providers and facilities that have distributed or implanted these devices should be aware of the recall and take appropriate action. While the document does not specify a compliance deadline for corrective actions, entities in possession of the affected product should consult Encore Medical's recall procedures. The recall is ongoing, and further information may be available through openFDA.

What to do next

  1. Review inventory for affected RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus (Model/Catalog Number: 509-00-432).
  2. Consult Encore Medical's recall procedures for handling and reporting.
  3. Notify affected patients and healthcare providers if necessary.

Source document (simplified)

Encore Medical, LP

Device Recalls (Class II)

← All Device Recalls (Class II) Class II Z-1458-2026 · 20260304 · Ongoing

Product

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

Reason for Recall

Knee and Humeral socket implants contain incorrect labeling.

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.

Source: openFDA Enforcement API

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
FDA
Filed
March 4th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
Z-1458-2026

Who this affects

Applies to
Healthcare providers Medical device makers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical Device Labeling Product Recall
Threshold
Class II
Geographic scope
United States US

Taxonomy

Primary area
Product Safety
Operational domain
Compliance
Topics
Medical Devices Labeling

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