HIGH

DJO Surgical Recalls Reamer Head Due to Binding Hazard

DJO Surgical recalled 927 units of the Altivate Reverse Wedge Glenoid Reamer Head on July 18, 2025. The recall follows reports that the device may kick or bind up during use. Healthcare providers and patients must stop using the product immediately.

Quick Facts at a Glance

Recall Date
July 18, 2025
Hazard Level
HIGH
Brand
DJO Surgical
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

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

Get instant alerts for Health & Personal Care recalls

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

No spamUnsubscribe anytime

Product Details

The recalled product is the Altivate Reverse Wedge Glenoid Reamer Head, model number 804-06-311. It is made from S.S/Nitronic and is non-sterile. The product was distributed nationwide in the United States.

The Hazard

Users may experience a kick or bind up of the reamer during or just before use. This malfunction can lead to potential injuries and complications.

Reported Incidents

There are no specific incident counts or injury reports mentioned. The potential for harm remains a serious concern.

What to Do

Stop using the Altivate Reverse Wedge Glenoid Reamer Head immediately. Contact Encore Medical, LP or your healthcare provider for further instructions and follow the recall instructions provided.

Contact Information

For more information, contact Encore Medical, LP via email. Visit the FDA website for details at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2546-2025.

Key Facts

  • Model Number: 804-06-311
  • Quantity Recalled: 927 units
  • Class II recall
  • Non-sterile surgical instrument

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
804-06-311
Affected States
ALL
Report Date
September 17, 2025
Recall Status
ACTIVE

Related Recalls

HIGH

Fresenius Kabi Vancomycin Injection Recalled Over Sterility Concerns

Fresenius Kabi Compounding recalled its vancomycin HCl injection on February 5, 2026, due to a lack of assurance of sterility. This Class II recall affects all lots distributed nationwide. Healthcare providers and consumers must stop using the product immediately.

Fresenius Kabi Compounding
Lack of
Read more
HIGH

Fresenius Kabi Compounding Issues Recall of Vancomycin Injection

Fresenius Kabi Compounding recalled 1,578 bags of vancomycin HCl injection on February 5, 2026. The company cited a lack of assurance of sterility as the reason for the recall. Healthcare providers and consumers should stop using the product immediately.

Fresenius Kabi Compounding
Lack of
Read more
HIGH

Pro Numb Tattoo Numbing Spray Recalled Due to cGMP Violations

Pro Numb Tattoo Numbing Spray was recalled on February 2, 2026 due to cGMP deviations. The product, containing 4% lidocaine, is distributed by Pro Numb Tattoo Numbing Spray LLC. Consumers should stop using it immediately and contact the company for further guidance.

PRO NUMB SENSITIVE SKIN
cGMP deviations
Read more