CLASS II Device recall · Reported 16 Jun 2021 · FDA Enforcement Report

DePuy Synthes Articul/eze Femoral Head recalled by DePuy Orthopaedics

DePuy Orthopaedics is recalling DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented, distributed in 21 states. The recall was initiated on 7 May 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: D20111130 GTIN: 10603295033172

Quantity recalled50 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1845-2021
FDA event ID: 87975
Recalling firm: DePuy Orthopaedics, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 7 May 2021
FDA classified: 10 Jun 2021
Reported: 16 Jun 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Hip & Knee Implants

Timeline

7 May 2021	Recall initiated by company
10 Jun 2021	Classified by FDA	+34 days
16 Jun 2021	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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

Where it was distributed

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

California Connecticut Florida Georgia Iowa Indiana Louisiana Maine Minnesota Missouri Montana North Carolina Nebraska New York Ohio Oklahoma Oregon Pennsylvania South Carolina Tennessee

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot: D20111130 GTIN: 10603295033172

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from DePuy Orthopaedics

All 153

Reported	Class	Recall	Company	Reason	Where
10 Apr 2024Device	CLASS II	Attune Affixium Cementless Fixed Bearing Knee recalled	DePuy Orthopaedics	Labeling Errors	Nationwide
29 Mar 2023Device	CLASS II	Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 recalled	DePuy Orthopaedics	Other	Nationwide
29 Mar 2023Device	CLASS II	Attune Revision Limb Preservation System (LPS) Tibial Insert XSM recalled	DePuy Orthopaedics	Other	Nationwide
29 Mar 2023Device	CLASS II	Attune Revision Limb Preservation System (LPS) Tibial Insert XSM recalled	DePuy Orthopaedics	Other	Nationwide
29 Mar 2023Device	CLASS II	Attune Revision Limb Preservation System (LPS) Tibial Insert SM recalled	DePuy Orthopaedics	Other	Nationwide

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