FDA Device recall Z-0769-2013

Trilogy F/M Acetabular Shell without holes

FDA Device
Class II
terminated
Published 2013-02-13

On 2013-02-13 the FDA classified a Class II recall of Trilogy F/M Acetabular Shell without holes by Zimmer, citing 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 10/31/201….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0769-2013
Classification	Class II
Status	terminated
Initiated	2012-09-14
Published	2013-02-13
Last updated	2026-09-13 11:53 UTC
Company	Zimmer
Distribution	US

Product

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.

Reason

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.

Identifiers

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code_info

61216907 61157229 00369603 61452214 00370029 00369698 61176450 00369643 00370031 61454835 00369732 00369699…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0769-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.