Z-2269-2021Class II

Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM Item Number:11-301325

Name: Z-2269-2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM Item Number:11-301325
Creator: Biomet, Inc.
Published: 2021-06-02
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2021-06-02 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM Item Number:11-301325 on 2021-06-02. FDA classified it as Class II and gives the reason as "Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention". 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-2269-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-02
Posted: 2021-08-12
Terminated: 2022-07-06
Recalling firm: Zimmer GmbH
Product: Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM Item Number:11-301325
Product code: KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Reason for recall: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Zimmer Biomet issued Urgent Medical Device Notification Letter on 6/2/21 to Distributors/ Risk Managers/Surgeons, stated reason for recall, health risk and action to take: Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with the field safety notice for hospitals and ensure documentation. 4. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form shall be returned even if you do not have affected products at your facility. 5. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 6. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected]. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. 3. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please ca
Quantity in commerce: 11 units
Distribution: US Nationwide distribution.
Product codes and lots: Lot Numbers/UDI : 880850 (01)00880304480575(17)310412(10)880850

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2269-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2259-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-12
Z-2260-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-12
Z-2261-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-12
Z-2262-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-12
Z-2263-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-12
Z-2264-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-12
Z-2265-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-12
Z-2266-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-12
Z-2267-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-12
Z-2268-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-12
Z-2269-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-12
Z-2270-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-12
Z-2271-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-12
Z-2272-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-12
Z-2273-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-12
Z-2274-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-12
Z-2275-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-12

Product code KWA

K090757Class IIIBiomet Modular Femoral Revision SystemBiomet, Inc. / cleared 2009-09-25

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)