FDA-Device2021-06-16Class II
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
DePuy Orthopaedics, Inc.
Hazard
Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.
Sold states
Domestic: CA, CT, FL, GA, IA, IN, LA, ME, MN, MO, MT, NC, NE, NY, OH, OK, OR, PA, SC, TN, WI. Foreign: Bermuda
Affected count
50 units
Manufactured in
700 Orthopaedic Dr, N/A, Warsaw, IN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1845-2021Don't want to check this manually?
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