ARTICUL/EZE recallZ-1845-2021 · DePuy Orthopaedics, Inc. · initiated May 7, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DePuy Orthopaedics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.
FDA root cause category: Employee error
What the company is doing
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.
Recall details
- Recall number
- Z-1845-2021
- Status
- Terminated
- Initiated by the company
- May 7, 2021
- Recalling firm
- DePuy Orthopaedics, Inc.
- Quantity
- 50 units
- Product code
- JDI
- FDA submissions
- K843909
- 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 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
Code information (models, lots, serial numbers)
Lot: D20111130 GTIN: 10603295033172
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K843909 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ARTICUL/EZE 1365-15-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented21 reports
- ARTICUL/EZE 1365-25-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented9 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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