HIGH

Encore Medical Recalled Humeral Socket Insert Over Labeling Issues

Encore Medical, LP recalled 20 units of its RSP Humeral Socket Insert on January 15, 2026. The recall stems from incorrect labeling on knee and humeral socket implants. Patients and healthcare providers should stop using the device immediately.

Quick Facts at a Glance

Recall Date
January 15, 2026
Hazard Level
HIGH
Brand
Encore Medical, LP
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Knee and Humeral socket implants contain incorrect labeling.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Encore Medical, LP or your healthcare provider for instructions. Notification method: Letter

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About This Product

The RSP Humeral Socket Insert is a medical device used in shoulder prosthesis surgeries. It serves to provide stability and support in the shoulder joint for patients undergoing surgical procedures.

Why This Is Dangerous

The incorrect labeling on the device may lead to confusion in usage, potentially resulting in improper implant procedures and patient safety risks.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall may cause inconvenience to patients and healthcare providers needing to replace or ensure the correct use of the implants.

Practical Guidance

How to identify if yours is affected

  1. Check the model number for 509-00-432.
  2. Look for the lot code: 385P1263 on the product packaging.
  3. Verify the product against the recall notice.

Where to find product info

Serial numbers and lot codes can typically be found on the product packaging or the device itself.

What timeline to expect

Expect a refund or replacement processing time of approximately 4-6 weeks.

If the manufacturer is unresponsive

  • Document all communication attempts with Encore Medical.
  • Consider contacting the FDA for further guidance.
  • Keep records of your product details and any correspondence.

How to prevent similar issues

  • Always verify product labels before usage.
  • Consult with healthcare providers regarding product recalls.
  • Stay informed about medical device safety updates.

Documentation advice

Keep a record of your purchase receipt, any correspondence with the manufacturer, and photos of the product.

Product Details

The recalled product is the RSP Humeral Socket Insert, 32MM +4MM, Standard HXe-plus, with model number 509-00-432. It was distributed nationwide, particularly in states including Virginia, Tennessee, and Illinois. The product is classified as Class II.

Key Facts

  • 20 units recalled
  • Incorrect labeling identified
  • Class II medical device
  • Nationwide distribution
  • Contact Encore Medical for instructions

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Lot Code: Lot: 385P1263 GTIN: 00888912144575
Affected States
ALL
Report Date
March 4, 2026
Recall Status
ACTIVE

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