Z-0628-2018Class II

AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804

Name: Z-0628-2018 AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804
Creator: Zimmer Biomet, Inc.
Published: 2017-08-25
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-08-25 / Terminated

FDA source

Zimmer Biomet, Inc. began a recall of AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product Usage: For use in Total Knee Arthroplasty on 2017-08-25. FDA classified it as Class II and gives the reason as "The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0628-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-25
Posted: 2018-02-15
Terminated: 2018-08-09
Recalling firm: Zimmer GmbH
Product: AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product Usage: For use in Total Knee Arthroplasty.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.
FDA root cause: Process change control
Action: Consignees were notified via mail on approximately 08/25/2017. Instructions to distributors, sales representatives, and distributor operations managers include to ensure affected team members are aware of the recall, locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement, return all affected product, and provide any additional hospitals and/or surgeons that received direct shipments. Instructions to risk managers and surgeons include to ensure affected personnel are informed of the recall, quarantine all affected product, return any affected product in inventory, and complete and return the Certificate of Acknowledgment. Questions or concerns can be sent to the Zimmer Biomet customer call center at 1-574-371-3071 between 8:00 am and 5:00 pm EST, Monday through Friday. Or they can be sent via email to [email protected].
Quantity in commerce: 11 devices
Distribution: US Nationwide Distribution to IN, MO, NY, TX.
Product codes and lots: Model No. 150804: Lot No. 088080 ((01)00880304240247(17)220606(10)088080), 305410 ((01)00880304240247(17)220601(10)305410).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0628-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0627-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-15
Z-0628-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-15

Product code JWH

K833921Class IIAgc Total Knee ProsthesisBiomet, Inc. / cleared 1984-01-31

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)