RecallRadar

FDA Device recall Z-1845-2021

DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis

On 2021-06-16 the FDA classified a Class II recall of DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis by Depuy Orthopaedics, citing fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1845-2021
ClassificationClass II
Statusterminated
Initiated2021-05-07
Published2021-06-16
Last updated2026-09-13 11:56 UTC
CompanyDepuy Orthopaedics
DistributionCA, CT, FL, GA, IA, IN, LA, ME, MN, MO, MT, NC, NE, NY, OH, OK, OR, PA, SC, TN, WI

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.

Identifiers

code_infoLot: D20111130 GTIN: 10603295033172

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1845-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.