CLASS II Device recall · Reported 13 Feb 2013 · FDA Enforcement Report

Trilogy F/M Acetabular Shell without holes Solid HA recalled by Zimmer

Zimmer is recalling Trilogy F/M Acetabular Shell without holes Solid HA, distributed nationwide in the US. The recall was initiated on 14 Sep 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes62245445 61633287 61709296 61633288 62252762 61843993 61992773 61761520 62215528 61398137 61338646 00115088 00115232 61403276 62167207 61371922 61807719 62005855 61330613 61490851 61514339 61761502 07892017 61268979 61278050 61278051 61338633 61354843 61384943 61622997 61693498 61730092 61780750 61831580 61581946 62109740 61227827 61645213 61461911 00113594 62252763 62016972 61930133 61236171 61499618 61693502 61926650 61962831 62049520 07892026 61268980 61330614 61371923 61398138 61449976 61490852 61581982 61603351 61629975 61639547 61748057 61772411 61801293 61831567 61851623 61366107 61278052 61278053 62084417 62185026 61227829 61338634 61658815 61476210 62245453 62056760 62030497 61761515 61236172 61366108 61403277 61566835 61596084 61813378 61860182 62011471 07892036 61203322 61268981 61278054 61278055 61281003 61338683 61360704 61371924 61419062 61449979 61490853 61581947 61622960 61633331 61737670 61784845 61831571 61962836 62180913 62078807 61227830 61645214 61476211 11000607 62011479 62042217 07891705 61603352 61278056 61338684 61366109 61769843 61831589 61973149 61236173 61268982 61278057 61278058 61333096 61371925 61514340 61633289 61791914 61813390 61860184 61946161 62084419 62245455 61429360 61645215 61227831 61384944 62270121 11000606 62049525 62005854 62159369 61680959 61851619 61596085 61792009 61236117 61268983 61278059 61278060 61338685 61366110 61371926 61639548 61819016 61398139 62011494 61670759 61950846 61603353 61278061 61419063 61490854 61761519 62126091 61843995 61622961

Quantity recalled275,952 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0770-2013
FDA event ID: 63531
Recalling firm: Zimmer, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 14 Sep 2012
FDA classified: 4 Feb 2013
Reported: 13 Feb 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

14 Sep 2012	Recall initiated by company
4 Feb 2013	Classified by FDA	+143 days
13 Feb 2013	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

Trilogy F/M Acetabular Shell without holes SOLID HA. Several ODs: 38MM, 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.

Where it was distributed

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.

Nationwide

Questions about this recall

Is Trilogy F/M Acetabular Shell without holes Solid HA recalled?

Yes. Zimmer recalled Trilogy F/M Acetabular Shell without holes Solid HA on 14 Sep 2012. The recall is Class II and its status is Terminated. Recall number Z-0770-2013.

Why was it recalled?

Which lots are affected?

62245445 61633287 61709296 61633288 62252762 61843993 61992773 61761520 62215528 61398137 61338646 00115088 00115232 61403276 62167207 61371922 61807719 62005855 61330613 61490851 61514339 61761502 07892017 61268979 61278050 61278051 61338633 61354843 61384943 61622997 61693498 61730092 61780750 61831580 61581946 62109740 61227827 61645213 61461911 00113594 62252763 62016972 61930133 61236171 61499618 61693502 61926650 61962831 62049520 07892026 61268980 61330614 61371923 61398138 61449976 61490852 61581982 61603351 61629975 61639547 61748057 61772411 61801293 61831567 61851623 61366107 61278052 61278053 62084417 62185026 61227829 61338634 61658815 61476210 62245453 62056760 62030497 61761515 61236172 61366108 61403277 61566835 61596084 61813378 61860182 62011471 07892036 61203322 61268981 61278054 61278055 61281003 61338683 61360704 61371924 61419062 61449979 61490853 61581947 61622960 61633331 61737670 61784845 61831571 61962836 62180913 62078807 61227830 61645214 61476211 11000607 62011479 62042217 07891705 61603352 61278056 61338684 61366109 61769843 61831589 61973149 61236173 61268982 61278057 61278058 61333096 61371925 61514340 61633289 61791914 61813390 61860184 61946161 62084419 62245455 61429360 61645215 61227831 61384944 62270121 11000606 62049525 62005854 62159369 61680959 61851619 61596085 61792009 61236117 61268983 61278059 61278060 61338685 61366110 61371926 61639548 61819016 61398139 62011494 61670759 61950846 61603353 61278061 61419063 61490854 61761519 62126091 61843995 61622961

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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