Recall Z-1845-2021— DePuy Orthopaedics, Inc.

Name: FDA recall Z-1845-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-07

Class II · Terminated

Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2021-05-07, terminated 2023-03-09. It names one FDA 510(k) clearance: K843909. 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: Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product..

Recalling firm: DePuy Orthopaedics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-05-07
Terminated: 2023-03-09
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K843909 — TITANIUM HIP 1019Depuy, Inc.·cleared 1984-11-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.