Z-1219-2017Class II

Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item...

Name: Z-1219-2017 Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item...
Creator: Zimmer Biomet, Inc.
Published: 2016-12-15
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2016-12-15 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No: 32-487263, 75 MM Item No: 32-487264, and 79 MM... on 2016-12-15. FDA classified it as Class II and gives the reason as "Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within...". 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-1219-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-15
Posted: 2017-02-16
Terminated: 2018-06-29
Recalling firm: Zimmer GmbH
Product: Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No: 32-487263, 75 MM Item No: 32-487264, and 79 MM Item No: 32-487265
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument
Quantity in commerce: 26
Distribution: Domestic: 0 Foreign: Singapore & Malaysia
Product codes and lots: Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No: 32-487263, 75 MM Item No: 32-487264, and 79 MM Item No: 32-487265; Lot No's: ZB160701, ZB160702, ZB160703, ZB160701, ZB160702, ZB160701, ZB160702, ZB160703, ZB160801, ZB160802, ZB160803, ZB160801, ZB160802

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1219-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1219-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-16

Product code JWH

K142933Class IIBiomet Tibial traysBiomet, Inc. / cleared 2014-12-23

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)