Z-0323-2012

ZMR Crossover Instrumentation, utilized for the following ZMR devices: Porous Stem,Nitrited Porous Revision...

Name: Z-0323-2012 ZMR Crossover Instrumentation, utilized for the following ZMR devices: Porous Stem,Nitrited Porous Revision...
Creator: Zimmer Inc.
Published: 2011-10-21
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2011-10-21 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Inc. began a recall of ZMR Crossover Instrumentation, utilized for the following ZMR devices: Porous Stem,Nitrited Porous Revision, Slotted Porous Bowed Stems with and without... on 2011-10-21. The reason FDA records is "This recall was initiated because it may not be clear to the surgeon whether the device can be used based on the instructions for use". 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-0323-2012
Status: Terminated
Initiated: 2011-10-21
Posted: 2011-12-01
Terminated: 2013-08-29
Recalling firm: Zimmer GmbH
Product: ZMR Crossover Instrumentation, utilized for the following ZMR devices: Porous Stem,Nitrited Porous Revision, Slotted Porous Bowed Stems with and without Compression Nut, Splined Straight Stem, Taper Stem and Bodies, Calcar Bodies, and Spout Bodies. Product Usage: The ZMR Hip Prosthesis is indicated for cementless total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: This recall was initiated because it may not be clear to the surgeon whether the device can be used based on the instructions for use.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The firm Zimmer, sent an "URGENT DEVICE CORRECTION" letter dated August 26, 2011 to Marketing Personnel, Distributors, Sales Representatives, Distribution Operation Managers, and Surgeons. The letters identified the reason for the recall, the product, and required actions to be taken. The letter also included Medwatch reporting information and a Certificate of Acknowledgement form to fax back to the recalling firm to confirm receipt of the recall notice. For questions contact Zimmer at 1-877-946-2761.
Quantity in commerce: 119,284 total devices
Distribution: Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Dubai/UAE, Eschbach, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Jordan, Israel, Korea, Lebanon, Mexico, Netherlands, New Zealand, Peru, Poland, Portugal, Russia, S. Africa, Saudi Arabia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, and Venezuela,
Product codes and lots: Catalog Number 97-9990-007-00 Revision 1, 2010. All lots for all devices

Product code LPH

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)