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Trilogy F/M Acetabular Shell with Uni-Hole recallZ-0771-2013 · Zimmer, Inc. · initiated Sep 14, 2012

Class II Terminated All recalls posted in February 2013

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

Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.

FDA root cause category: Process control

What the company is doing

Zimmer sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated September 20, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.The firm expanded the scope of the recall in January 2013 to include devices that use a secondary mean of fixation. New recall letters will be submitted to distributors and surgeons.

Recall details

Recall number
Z-0771-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 14, 2012
Posted by the FDA
Feb 4, 2013
Recalling firm
Zimmer, Inc.
Quantity
275,952 units
Product code
LPH
FDA submissions
K934765
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Denmark, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Spain, Sweden, UK, Poland, France, Australia, Chile, Canada, India, Japan, New Zealand, Peru, South Africa, Colombia, Ukraine, and UAE.

Product description

Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.

Code information (models, lots, serial numbers)

61282267 61633887 61260645 61237937 61500763 61397941 61584769 61199849 61429445 61412089 00369745

Other devices under the same FDA submission

8 devices cleared under K934765 — 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 63531).

Sources and updates

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