Z-2820-2018Class II

ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem

Name: Z-2820-2018 ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem
Creator: Zimmer Biomet, Inc.
Published: 2018-06-08
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-06-08 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem on 2018-06-08. FDA classified it as Class II and gives the reason as "Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component". 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-2820-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-08
Posted: 2018-08-14
Terminated: 2020-04-14
Recalling firm: Zimmer GmbH
Product: ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm sent an initial email on June 6, 2018, to US distributors that received affected product. Distributors were asked to quarantine any affected product on hand. The formal recall notice was then prepared and emailed to distributors on June 8, 2018. On the same day, hospital risk managers and distributors received notification via courier. " The distributors notice identified the issue and their responsibilities. These responsibilities included locating and removing the product in their territory, as well as identifying hospitals who have previously used the product. " Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. " The hospital risk manager notice identified the issue and their responsibilities. These responsibilities include: - Assisting the Zimmer Biomet sales representative with the quarantine of the product - Returning Certificate of Acknowledgement to Zimmer Biomet. If you have further questions or concerns after reviewing this information, please call Zimmer Biomet 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].
Quantity in commerce: 12
Distribution: US distribution to CA, GA, IL, MO, NY, and VA.
Product codes and lots: lot 621550 UDI (01)00880304474154(17)280206(10)621550

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2820-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2820-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-14
Z-2821-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-14

Product code JDI

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)