Z-0386-2013Class II

Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a...

Name: Z-0386-2013 Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a...
Creator: Zimmer, Inc.
Published: 2012-08-27
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-08-27 / Terminated / root cause: labeling and UDI

FDA source

Zimmer, Inc. began a recall of Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthroplasty on 2012-08-27. FDA classified it as Class II and gives the reason as "Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is packaged in the incorrect carton. Product labels and patient labels are correct, matching the product inside the carton". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0386-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-27
Posted: 2012-11-20
Terminated: 2013-08-27
Recalling firm: Zimmer GmbH
Product: Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthroplasty.
Product code: KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Reason for recall: Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is packaged in the incorrect carton. Product labels and patient labels are correct, matching the product inside the carton.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Zimmer contacted their customer beginning the week of August 27, 2012, via telephone. Zimmer informed the customer the reason of the recall. The customer was instructed to quarantine and return the device to Zimmer Product Service, 1777 W. Center St. Warsaw, IN 46580. The customer was asked to provide information if the product was further distributed. For further questions please call 574-372-4316.
Quantity in commerce: 1
Distribution: USA (nationwide) including the states of Ohio, Carolinas and New England.
Product codes and lots: Item 00-6334-062-36, Lot 62023769

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0386-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0386-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-20

Product code KWZ

K071718Class IITrilogy Longevity Constrained LinerZimmer, Inc. / cleared 2007-07-13

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)