Recall Z-2546-2025— Encore Medical, LP

Name: FDA recall Z-2546-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-18

Class II · Ongoing

Class II FDA medical device recall by Encore Medical, LP, initiated 2025-07-18. It names one FDA 510(k) clearance: K233481. 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. Reason: Their is a potential that the reamer may kick or bind up during or immediately prior to use..

Recalling firm: Encore Medical, LP
Classification: Class II
Status: Ongoing
Initiated: 2025-07-18
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K233481 — AltiVate Reverse® GlenoidEncore Medical L.P.·cleared 2024-05-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.