Z-0771-2013Class II

Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System is indicated for either cemented or...

Name: Z-0771-2013 Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System is indicated for either cemented or...
Creator: Zimmer, Inc.
Published: 2012-09-14
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-09-14 / Terminated / root cause: manufacturing process

FDA source

Zimmer, Inc. began a recall of Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery... on 2012-09-14. FDA classified it as Class II and gives the reason as "Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action...". 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-0771-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-14
Posted: 2013-02-04
Terminated: 2014-06-20
Recalling firm: Zimmer GmbH
Product: Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Zimmer sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated September 20, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.The firm expanded the scope of the recall in January 2013 to include devices that use a secondary mean of fixation. New recall letters will be submitted to distributors and surgeons.
Quantity in commerce: 275,952 units
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Denmark, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Spain, Sweden, UK, Poland, France, Australia, Chile, Canada, India, Japan, New Zealand, Peru, South Africa, Colombia, Ukraine, and UAE.
Product codes and lots: 61282267 61633887 61260645 61237937 61500763 61397941 61584769 61199849 61429445 61412089 00369745

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0771-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0769-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-13	2013-02-04
Z-0770-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-13	2013-02-04
Z-0771-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-13	2013-02-04
Z-0772-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-13	2013-02-04
Z-0773-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-13	2013-02-04
Z-0774-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-13	2013-02-04
Z-0775-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-13	2013-02-04
Z-0776-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-13	2013-02-04

Product code LPH

K934765Class IITrilogy Acetabular SystemZimmer, Inc. / cleared 1994-04-29

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)