Z-1845-2021Class II

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

Name: Z-1845-2021 DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part...
Creator: DePuy Orthopaedics, Inc.
Published: 2021-05-07
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2021-05-07 / Terminated / root cause: manufacturing process

FDA source

DePuy Orthopaedics, Inc. began a recall of DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE... on 2021-05-07. FDA classified it as Class II and gives the reason as "Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1845-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-07
Posted: 2021-06-10
Terminated: 2023-03-09
Recalling firm: Depuy Orthopaedics Inc.
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
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On May 12, 2021, DePuy Synthes issued an Urgent Medical Device Removal notice to customers via letter notifying them that DePuy Synthes has determined that individual units of ARTICUL/EZETM Femoral Heads were distributed with the incorrect part number and size etched on the product. Please take the Following Steps: 1. Examine your inventory immediately to determine if you have the lot subject to this recall and quarantine the product. 2. Contact your DePuy Synthes Sales Consultant to coordinate the return of any products from the affected lot. 3. Complete, sign and return the attached business response form (see page 3 of this notice) to [email protected] 4. Forward this notice to anyone in your facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the project subject to this recall). 5. If any of the subject product has been forwarded to another facility, contact that facility and provide them with this notice. 6. Post a copy of this notice in a visible area for awareness and keep a copy for your records.
Quantity in commerce: 50 units
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
Product codes and lots: Lot: D20111130 GTIN: 10603295033172

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1845-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1845-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-10

Product code JDI

K843909Class IITitanium Hip 1019Depuy, Inc. / cleared 1984-11-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)