FDA Medical devices recall ·
DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model recall
- Recall number
- Z-2546-2025
- Date
- (initiated July 18, 2025)
- Company / brand
- Encore Medical, LP
9800 Metric Blvd, Austin, TX, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 927 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Product Description: Material: S.S/Nitronic, Non-Sterile
Why was it recalled?
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: Item Number: All Lots GTIN: 00190446843825
Distribution
US Nationwide distribution in the states of 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.
States: Alabama Arizona California Colorado Florida Hawaii Iowa Illinois Indiana Kansas Kentucky Louisiana Maryland Maine Nebraska New Jersey New York Ohio Puerto Rico Rhode Island South Carolina Tennessee Texas Utah Virginia Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2546-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.