FDA recall Z-2546-2025

Encore Medical, LP · Class II · device

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 for recall

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

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.

Key facts

Status
Ongoing
Initiation date
2025-07-18
Report date
2025-09-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2546-2025