Z-0366-2012

Zimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Primary Hip Prosthesis Femoral Stem SIZE 16 171...

Name: Z-0366-2012 Zimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Primary Hip Prosthesis Femoral Stem SIZE 16 171...
Creator: Zimmer Inc.
Published: 2011-11-16
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2011-11-16 / Terminated / root cause: manufacturing process

FDA source

Zimmer Inc. began a recall of Zimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Primary Hip Prosthesis Femoral Stem SIZE 16 171 MM STEM LENGTH 12/14 NECK TAPER - STANDARD BODY -... on 2011-11-16. The reason FDA records is "Lack of assurance of proper metal fatigue strength due to metal grain structure anomaly. In 2006 a recall was initiated as a result of the grain anomaly; however, these 4 lots had been split off during normal production...". 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-0366-2012
Status: Terminated
Initiated: 2011-11-16
Posted: 2015-06-26
Terminated: 2013-08-28
Recalling firm: Zimmer GmbH
Product: Zimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Primary Hip Prosthesis Femoral Stem SIZE 16 171 MM STEM LENGTH 12/14 NECK TAPER - STANDARD BODY - STANDARD NECK OFFSET TIVANIUM TI-6AL-4V ALLOY/TANTALUM STERILE. Item number: 00-7864-016-00
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Lack of assurance of proper metal fatigue strength due to metal grain structure anomaly. In 2006 a recall was initiated as a result of the grain anomaly; however, these 4 lots had been split off during normal production and had not been included in the 2006 recall.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 11/16/11, Zimmer sent letters titled "URGENT MEDICAL DEVICE RECALL" to distributors via electronic mail and to risk managers and surgeons via FedEx indicating that the product must be immediately removed from use and quarantined. " Stop using the affected lots and place affected product in quarantine. " Review available product on the shelf " Identify those part/lot combinations listed in the recall communication " Immediately remove any implants found that match part/lot combinations listed in the recall communication and quarantine " Return affected lots and signature of acknowledgement to Zimmer
Quantity in commerce: 2 (1 device is domestic)
Distribution: Worldwide distribution: USA (NY), AUSTRALIA, SWITZERLAND, and DENMARK
Product codes and lots: Item number: 00-7864-016-00 Lot number: 00104820

Product code LPH

K051491Class IITrabecular Metal Primary Hip ProsthesisZimmer, Inc. / cleared 2005-06-30

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)