Medical device recalls Moderate risk

Encore Medical product recalled over sterility concerns

Recall date
July 18, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Encore Medical, LP recalls Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Prod…
Recall number
Z-2546-2025
FDA classification
Class II
Brand / firm
Encore Medical, LP
Sold / distributed
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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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