Z-0060-2011

Zimmer Trabecular metal Modular Acetabular system 56 mm Porous shell with cluster holes, Catalog...

Name: Z-0060-2011 Zimmer Trabecular metal Modular Acetabular system 56 mm Porous shell with cluster holes, Catalog...
Creator: Zimmer Inc.
Published: 2010-08-18
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2010-08-18 / Terminated

FDA source

Zimmer Inc. began a recall of Zimmer Trabecular metal Modular Acetabular system 56 mm Porous shell with cluster holes, Catalog 00-6202-056-22, Zimmer Inc., Warsaw, IN. This device is... on 2010-08-18. The reason FDA records is "The threads on the device were not completely machined and therefore would not mate with athe corresponding cup positioner/shell inserter". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0060-2011
Status: Terminated
Initiated: 2010-08-18
Posted: 2010-10-14
Terminated: 2011-02-07
Recalling firm: Zimmer GmbH
Product: Zimmer Trabecular metal Modular Acetabular system 56 mm Porous shell with cluster holes, Catalog 00-6202-056-22, Zimmer Inc., Warsaw, IN. This device is indicated for primary or revision surgery for rehabilitating hips damaged as the result of noninflammatory degenerative joint disease, including osteoarthritis, fused hip, avascular necrosis, traumatic arthritis and fracture of the pelvis.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: The threads on the device were not completely machined and therefore would not mate with athe corresponding cup positioner/shell inserter.
FDA root cause: Other
Action: The firm, Zimmer, made telephone calls using a phone script document entitled "Urgent: Medical Device Recall" Phone Script Call Communication, to the customers that received this product starting on 8/18/2010. The telephone calls were to determine the status of the recalled product. A Zimmer Field Action Strategy notification dated August 9, 2010 was also provided. The notifications/phone script described the product, problem and actions to be taken by the customers. The customers were instructed to remove the 00-6202-056-22, lot 61091653 product from their inventory and return to Zimmer Product Service Department, Attn: Product Service, 1777 West Center Street, Warsaw, IN 45680. Note: If the product had been used, no action was necessary. The returned product will be evaluated to determine how many of the devices had the defect. If you have any questions, please call (574) 371-8852.
Quantity in commerce: 24
Distribution: Worldwide distribution:USA including states of: MI, IN, WI, MO, CA, VA, MD, TX, NC, PA, OR, WA, FL, GA, NY, ME, AZ, and UT and country including Canada.
Product codes and lots: 61091653

Product code LPH

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)