Z-0416-2013Class II

The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile The Trilogy Acetabular...

Name: Z-0416-2013 The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile The Trilogy Acetabular...
Creator: Zimmer, Inc.
Published: 2012-09-20
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-09-20 / Terminated / root cause: manufacturing process

FDA source

Zimmer, Inc. began a recall of The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile The Trilogy Acetabular System is indicated for either cemented or uncemented... on 2012-09-20. FDA classified it as Class II and gives the reason as "Zimmer Trilogy Acetabular System Shell with Cluster Holes, Porous,56 MM O.D., sterile; is missing polar hole threads. Zimmer received one complaint in which no injury was reported". 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-0416-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-20
Posted: 2012-11-21
Terminated: 2014-04-18
Recalling firm: Zimmer GmbH
Product: The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile The Trilogy Acetabular System is indicated for either cemented or uncemented use In skeletally mature Individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused Hip, fracture of the pelvis, and diastrophic variant. The shells with screw holes permit the use of titanium alloy screws to provide additional fixation and security, particularly in those cases where acetabular bone stock is deficient.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Zimmer Trilogy Acetabular System Shell with Cluster Holes, Porous,56 MM O.D., sterile; is missing polar hole threads. Zimmer received one complaint in which no injury was reported.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Zimmer sent a Urgent Medical Device Recall Notice dated September 20, 2012, to all affected customers. The letter identified the products the problem and the action needed to be taken by the customer. Customers were instructed to locate quarantine and return affected product to Zimmer Product Service Department, 1777 West center St. Warsaw, IN 46580 for product in the USA. Customers were asked to complete the Inventory Return Certification Form and follow the instructions where to return this form. For further questions please call (574) 372-4807.
Quantity in commerce: 24 USA; 71 worldwide
Distribution: Worldwide Distribution--USA (nationwide) including the states of AL, CA, CT, KS, MA, MD, MN, MO, NY, SD, TX and WI and the countries of Bulgaria,Canada, Germany, Italy, Netherlands, Russian Fed, Sweden and UK
Product codes and lots: REF 6200-056-22, lot 62010615

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0416-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0416-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-21

Product code LPH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)