Skip to content

ZMR Crossover Instrumentation, utilized for the following… recallZ-0323-2012 · Zimmer Inc. · initiated Oct 21, 2011

Terminated All recalls posted in December 2011

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Error in labeling

What the company is doing

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.

Recall details

Recall number
Z-0323-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 21, 2011
Posted by the FDA
Dec 1, 2011
Recalling firm
Zimmer Inc.
Quantity
119,284 total devices
Product code
LPH
FDA submissions
K031572, K994286
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 description

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.

Code information (models, lots, serial numbers)

Catalog Number 97-9990-007-00 Revision 1, 2010. All lots for all devices

Other devices under the same FDA submission

5 devices cleared under K031572, K994286 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 59814).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page