HIGH

DJO Surgical AltiVate Reverse Glenoid Tray Recall Affects 439 Kits Nationwide (2025)

DJO Surgical recall affects 439 AltiVate Reverse Glenoid Tray kits distributed across 26 states and Puerto Rico. A reamer in the kit may kick or bind during use. Patients and clinicians should stop using the device and follow manufacturer instructions.

Quick Facts at a Glance

Recall Date
July 18, 2025
Hazard Level
HIGH
Brands
DJO Surgical, Enovis, Encore Medical
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL, PREGNANT

Hazard Information

Their is a potential that the reamer may kick or bind up during or immediately prior to use.

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: E-Mail

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About This Product

Enovis shoulder devices require precise instrumentation for implantation. The AltiVate reverse prosthesis is used in complex shoulder arthroplasty.

Why This Is Dangerous

A reamer in the kit may kick or bind during use, potentially affecting surgical safety and outcomes.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Hospitals may face delays in procedures; clinicians must halt use of the affected kits.

Practical Guidance

How to identify if yours is affected

  1. Check the kit lot number against recall notice
  2. Verify that your facility has the affected 439 kits
  3. Review device labeling for AltiVate Reverse Glenoid Tray
  4. Confirm if replacement kits are being sent by Enovis

Where to find product info

FDA enforcement page Z-2549-2025; recall notice from Enovis/Encore Medical

What timeline to expect

Replacement or remediation timelines will be provided by the manufacturer; typical replacement windows span weeks to a couple of months

If the manufacturer is unresponsive

  • Log all communications with the manufacturer
  • File a complaint with the relevant medical device regulator if needed
  • Consider elective procedure postponement if feasible

How to prevent similar issues

  • Verify instrument compatibility before procedures
  • Maintain updated recall lists
  • Ensure sterile processing follows device-specific instructions

Documentation advice

Keep all recall notices, lot numbers, and correspondence; document surgeries affected and any remediation steps

Product Details

Brand: DJO Surgical. Product: FA S AltiVate Reverse Glenoid Tray. Model/Catalog Number: None. Distribution: US nationwide in AL, AZ, CA, CO, FL, HI, IA, IL, IN, KS, KY, LA, MD, ME, NE, NJ, NY, OH, PR, RI, SC, TN, TX, UT, VA, WA, WI. Quantity: 439 kits. Recall date: 2025-07-18. Status: Active.

Reported Incidents

No specific injuries or incidents are reported in the provided data.

Key Facts

  • 439 kits recalled
  • Nationwide distribution across 26 states and Puerto Rico
  • High-risk Class II device
  • Reamer may kick or bind during use
  • No injuries reported in provided documentation

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
GENERALPREGNANT
Injury Types
LACERATIONOTHER

Product Classification

Product Details

Model Numbers
AltiVate Reverse Glenoid Tray
Affected States
ALL
Report Date
September 17, 2025
Recall Status
ACTIVE

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