Z-0723-2021Class II

Vanguard 360 Revision System Posterior Augment With Bolt -

Name: Z-0723-2021 Vanguard 360 Revision System Posterior Augment With Bolt -
Creator: Biomet, Inc.
Published: 2020-12-01
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2020-12-01 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422 on 2020-12-01. FDA classified it as Class II and gives the reason as "Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure". 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-0723-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-01
Posted: 2020-12-23
Terminated: 2022-07-08
Recalling firm: Zimmer GmbH
Product: Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure
Root cause tag: manufacturing process
FDA root cause: Process control
Action: .Zimmer Biomet issued Urgent Medical Device Recall letter issued on 12/1/20 to distributors with direct sales and/or fielded inventory via email and traceable letter sent via FedEx. Hospitals with direct sales or current inventory will be notified via FedEx. Letter states reason for recall , health risk and action to take: Distributors esponsibilities include: locating and removing the product in their territory, as well as identifying hospitals who have previously used the product. 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].
Quantity in commerce: 21 units
Distribution: Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Korea, Japan, Netherlands.
Product codes and lots: Lot Number: 098780 UDI Number: (01) 00880304482739 (17) 290501 (10) 098780

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0723-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0723-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23

Product code JWH

K093293Class IIVanguard 360 Revision Knee SystemBiomet, Inc. / cleared 2010-10-22

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)