FDA recall Z-1845-2021

DePuy Orthopaedics, Inc. · Class II · device

Product

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

Reason for recall

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

Distribution

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

Key facts

Status: Terminated
Initiation date: 2021-05-07
Report date: 2021-06-16
Termination date: 2023-03-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1845-2021