Z-3249-2018Class II

Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for...

Name: Z-3249-2018 Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for...
Creator: Zimmer Biomet, Inc.
Published: 2018-08-02
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-08-02 / Terminated / root cause: packaging

FDA source

Zimmer Biomet, Inc. began a recall of Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty on 2018-08-02. FDA classified it as Class II and gives the reason as "The implant only has one bolt in the sterile package but it should have had two". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-3249-2018
Classification: Class II
Status: Terminated
Initiated: 2018-08-02
Posted: 2018-09-25
Terminated: 2019-04-25
Recalling firm: Zimmer GmbH
Product: Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The implant only has one bolt in the sterile package but it should have had two.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL" notification letters dated 8/2/18 to customers on 8/2/18. The letters described the product, problem and actions to be taken. The letters instruct customers to perform the following actions: 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. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form must be returned even if you do not have affected products at your facility. 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 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]. Distributors: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1 Inventory Return Certification Form and send to [email protected] within three (3) days. b. For each return, send a copy of Attachment 1 to [email protected]. c. Include a hardcopy of Attachment 1 in each carton of your retur
Quantity in commerce: 16
Distribution: Worldwide Distribution: US (nationwide) to the following US states: AZ, KS, NM, NV, and UT; and to countries of: Australia and Netherlands.
Product codes and lots: Lot 320390, UDI (01) 0088030448157 (17) 230129 (10) 320390

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3249-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3249-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-25
Z-3250-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-25

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)