HIGH

Encore Medical Recalls Shoulder Prosthesis Over Labeling Error

Encore Medical, LP recalled 20 shoulder prosthesis implants on January 15, 2026. Incorrect labeling on the RSP Standard Humeral Socket Insert poses a high hazard risk. Affected products were distributed nationwide across multiple states.

Quick Facts at a Glance

Recall Date
January 15, 2026
Hazard Level
HIGH
Brand
Encore Medical, LP
Category
Health & Personal Care
Sold At
Multiple Retailers
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

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

About This Product

The RSP Standard Humeral Socket Insert is part of a reverse shoulder prosthesis system used in orthopedic surgeries. Surgeons use this device to help restore mobility in patients with shoulder issues.

Why This Is Dangerous

The incorrect labeling may lead to improper use during surgery, potentially resulting in complications for patients. Proper identification and usage are critical for patient safety.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients may face delays in treatment and increased risk if they have used the recalled implant. The urgency to address the recall is high due to potential complications.

Practical Guidance

How to identify if yours is affected

  1. Check the product packaging for the model number 509-00-036 and lot code 378P1382.
  2. Confirm if the shoulder prosthesis matches the recalled description.
  3. Consult your healthcare provider if you are uncertain about your implant.

Where to find product info

Look for the model number and lot code on the product packaging or accompanying documentation.

What timeline to expect

Expect a processing timeline of 4-6 weeks for refunds or other actions.

If the manufacturer is unresponsive

  • Follow up with Encore Medical via phone or email if you receive no response within a week.
  • Document all communication attempts in case further escalation is necessary.

How to prevent similar issues

  • Ensure that any medical device purchased has clear labeling and certification.
  • Consult with healthcare professionals about the safety and recall history of medical devices before use.
  • Stay informed about recalls in the medical device industry.

Documentation advice

Keep copies of any correspondence related to the recall, including emails and letters from the manufacturer.

Product Details

The recall affects the RSP Standard Humeral Socket Insert, 36MM, model number 509-00-036. The affected lot code is 378P1382. The implants were sold nationwide in states including Virginia, Tennessee, Illinois, Indiana, Michigan, Colorado, Wyoming, Montana, Rhode Island, Massachusetts, New Jersey, Pennsylvania, Missouri, Oklahoma, Louisiana, Florida, and California.

Key Facts

  • Recall date: January 15, 2026
  • 20 shoulder prosthesis implants affected
  • High hazard risk due to incorrect labeling
  • Distributed nationwide in multiple states
  • Contact Encore Medical for further 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

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

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

Product Classification

Product Details

Model Numbers
Lot Code: Lot: 378P1382 GTIN: 00888912144544
Affected States
ALL
Report Date
March 4, 2026
Recall Status
ACTIVE

Related Recalls

Health & Personal Care
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.

Encore Medical, LP
Knee and
Read more
Health & Personal Care
HIGH

Encore Medical Recalls EMPOWR Acetabular System Over Packaging Errors

Encore Medical, LP recalled 49 units of the EMPOWR Acetabular System on January 5, 2026. Packaging errors may cause surgical delays, potentially affecting patient safety. Healthcare providers should stop using these devices immediately.

Encore Medical, LP
942-01-40G acetabular
Read more
Health & Personal Care
HIGH

Encore Medical Recalls Knee Tibial Insert Due to Packaging Error

Encore Medical, LP recalled 19 units of the EMPOWR 3D Knee Tibial Insert on January 5, 2026. The recall follows the discovery of a packaging error that may cause surgical delays. Healthcare providers and patients should stop using the device immediately.

Encore Medical, LP
942-01-40G acetabular
Read more