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Trilogy F/M Acetabular Shell without holes. Several ODs:… recallZ-0769-2013 · 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-0769-2013
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 without holes. Several ODs: 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. 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)

Show the full code information (2k characters)

61216907 61157229 00369603 61452214 00370029 00369698 61176450 00369643 00370031 61454835 00369732 00369699 61216908 61673516 61642322 62065259 61906448 61263152 61454836 61476896 00369630 61775736 61943339 61403525 61642325 61732773 61263539 61642324 61906449 62022702 62076908 61885843 61309789 61928501 61237709 61292681 61407876 61825843 61452216 61817457 61237707 61237708 61271325 61327754 61452215 61452217 61489313 61519975 61536413 61564182 61598285 61642323 00370315 00369632 61744558 61885845 62079957 61732772 61928502 61783457 61825844 61869694 61906453 62010604 61846487 61993146 61642326 61779030 61783460 61906450 62052790 61536692 61487482 61487481 61598295 61632192 61309790 61511677 61455839 61263540 61367254 61321073 61237710 61281183 61455840 00369649 61976102 61788120 61885847 61928503 61801103 61840614 61947562 61996712 61813950 61899040 61911390 62001304 61864069 61536693 61473713 61417315 62076907 61487483 61489314 61281184 61237711 61237712 61642328 61260584 61306613 61329094 61403527 61455843 61598296 61642327 00369605 61642329 61813945 61980779 61947563 62076909 61928504 61955589 61292682 62006523 61801104 61813948 61864070 61885848 61906451 61476897 61612715 61642330 61470887 61417316 61473724 61567576 61256570 61455841 61215903 61237713 61281185 61309791 61397913 61536694 00369645 61728663 61775735 61801102 61864071 61996713 61292684 61642332 61891249 61526509 61611815 61976103 61760310 61768196 61951207 62043439 61235829 61237714 61271326 61429593 61500680 61526508 61611819 61817458 62079956 61260587 61452212 61321074 61403528 61417317 61469130 61500681 61801101 61825845 61911391 62065258 61350519 00369738 00369635 61548179 61928505 61532294 61548180 61642333 61803766 61983681 62036846 61237716 61309792 61403529 61412049 61889258 61256571 61424318 61455846 61476898 62006522 00369803 61921682 61873604 61500682 61318326 61987182 61350520 00369741 00369702 00369639 61452213 00369640 61724206 00369705

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

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