Z-3279-2011

The Trabecular Metal Modular Acetabular System is a modular acetabular cup system consisting of a shell with...

Name: Z-3279-2011 The Trabecular Metal Modular Acetabular System is a modular acetabular cup system consisting of a shell with...
Creator: Zimmer Inc.
Published: 2011-09-01
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2011-09-01 / Terminated / root cause: manufacturing process

FDA source

Zimmer Inc. began a recall of The Trabecular Metal Modular Acetabular System is a modular acetabular cup system consisting of a shell with a preassembled locking ring, a liner, and optional... on 2011-09-01. The reason FDA records is "Lot # 61132698 and Lot 001122467 (added 9/ 18/2012) may have a manufacturing non conformance that could prevent the devices from functioning as intended. Specifically, devices in the affected lot may have a locking ring...". 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-3279-2011
Status: Terminated
Initiated: 2011-09-01
Posted: 2011-09-27
Terminated: 2013-08-29
Recalling firm: Zimmer GmbH
Product: The Trabecular Metal Modular Acetabular System is a modular acetabular cup system consisting of a shell with a preassembled locking ring, a liner, and optional screws. The Shells are available in a variety of sizes and are designed to be used with Trilogy Acetabular System liners. The shell implants are used to replace the hip socket during total hip arthroplasty. The device is indicated for primary or revision surgery for rehabilitating hips damaged as a result on 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 device is intended for either cemented or noncemented use.
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: Lot # 61132698 and Lot 001122467 (added 9/ 18/2012) may have a manufacturing non conformance that could prevent the devices from functioning as intended. Specifically, devices in the affected lot may have a locking ring groove depth that prevents the corresponding liner from snapping into the shell. The groove provides the locking ring room to displace when inserting a liner into the shell. Th
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Zimmer, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated July 27, 2011 to all affected customers of lot 61132698 and 9/18/2012 to only affected customer of lot 001122467. The letters describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to stop using and to quarantine the affected product. An Inventory Return Certification Form was included with the letter for customers to complete and return to Zimmer, Inc. via fax at (574) 372-4265. Replacement product will be provided for all returned product. Contact Zimmer, Inc. at 1-800-613-6131 for questions regarding this recall.
Quantity in commerce: 24 devices lot 61132689; 1 device lot 001122467
Distribution: Worldwide Distribution-USA (nationwide) including the states of CA, NC,NY, PA, WA, and WI and countries of Australia, Germany, The Netherlands, and Switzerland.
Product codes and lots: Part 00-6202-052-21, Lot 61132698 and lot 001122467

Product code JDI

K021891Class IIZimmer Trabecular Metal Modular Acetabular SystemZimmer, Inc. / cleared 2002-09-05

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)