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Urgent Enforcement Amended Final

Encore Medical LP Shoulder Implant Recall - 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 LP'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) Standard Humeral Socket Insert, 36MM, HXe-plus (Model/Catalog Number: 509-00-036) due to incorrect labeling on knee and humeral socket implants. This recall is classified as Class II, indicating that the use of or exposure to a faulty product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote.

This recall impacts nationwide distribution across multiple US states. Healthcare providers and distributors who have received these affected products should cease distribution and contact Encore Medical LP to arrange for return or other corrective actions. Patients who have received implants with this incorrect labeling should consult their healthcare provider to discuss potential risks and management.

What to do next

  1. Cease distribution of affected RSP implants.
  2. Contact Encore Medical LP for return or corrective action instructions.
  3. Notify healthcare providers and patients about the incorrect labeling.

Source document (simplified)

Encore Medical, LP

Device Recalls (Class II)

← All Device Recalls (Class II) Class II Z-1460-2026 · 20260304 · Ongoing

Product

Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036

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-1460-2026

Who this affects

Applies to
Medical device makers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Device Recalls
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Compliance
Topics
Product Safety Labeling

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