DePuy Orthopaedics, Inc. recalls DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365…

Recall date

May 7, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1845-2021

FDA classification

Class II

Brand / firm

DePuy Orthopaedics, Inc.

Sold / distributed

Domestic: CA, CT, FL, GA, IA, IN, LA, ME, MN, MO, MT, NC, NE, NY, OH, OK, OR, PA, SC, TN, WI. Foreign: Bermuda

Why it was recalled

Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.

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

What was recalled

DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR