Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm ...
FDA Recall #Z-2547-2025 — Class II — July 18, 2025
Product Description
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804-06-312 Product Description: Material: S.S., Non Sterile
Reason for Recall
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Recalling Firm
Encore Medical, LP — Austin, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
907 units
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.
Code Information
Lot Code: All Lots GTIN: 00190446843832
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated