Product 63 consists of all product under
Medical device recall Z-1161-2016. Published in FDA’s Enforcement Report on Mar 23, 2016.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 23, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 2063 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Product 63 consists of all product under product code: LPH and same usage: Item no: 620004020 TRILOGY ACET SHELL 40MM O 620004220 TRILOGY ACET SHELL 42MM O 620004420 TRILOGY ACET SHELL 44MM O 620004620 TRILOGY ACET SHELL 46MM O 620004621 TRILOGY ACET SHELL 46MM O 620004820 TRILOGY ACET SHELL 48MM O 620004822 TRILOGY ACET SHELL 48MM O 620004823 TRILOGY ACET SHELL 48MM O 620005020 TRILOGY ACET SHELL 50MM O 620005021 TRILOGY ACET SHELL 50MM O 620005022 TRILOGY ACET SHELL 50MM O 620005220 TRILOGY ACET SHELL 52MM O 620005221 TRILOGY ACET SHELL 52MM O 620005222 TRILOGY ACET SHELL 52MM O 620005223 TRILOGY ACET SHELL 52MM O 620005420 TRILOGY ACET SHELL 54MM O 620005421 TRILOGY ACET SHELL 54MM O 620005422 TRILOGY ACET SHELL 54MM O 620005423 TRILOGY ACET SHELL 54MM O 620005620 TRILOGY ACET SHELL 56MM O 620005621 TRILOGY ACET SHELL 56MM O 620005622 TRILOGY ACET SHELL 56MM O 620005623 TRILOGY ACET SHELL 56MM O 620005820 TRILOGY ACET SHELL 58MM O 620005821 TRILOGY ACET SHELL 58MM O 620005822 TRILOGY ACET SHELL 58MM O 620005823 TRILOGY ACET SHELL 58MM O 620006020 TRILOGY ACET SHELL 60MM O 620006022 TRILOGY ACET SHELL 60MM O 620006023 TRILOGY ACET SHELL 60MM O 620006021 TRILOGY ACET SHELL 60MM OD SOLID 620006220 TRILOGY ACET SHELL 62MM O 620006221 TRILOGY ACET SHELL 62MM O 620006222 TRILOGY ACET SHELL 62MM O 620006420 TRILOGY ACET SHELL 64MM O 620006422 TRILOGY ACET SHELL 64MM O 620006620 TRILOGY ACET SHELL 66MM O For use in total hip arthroplasty
2063, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
lot no.: 61564135 62126347 61564135R 62251853 62298252 62298252N 61873598 62156174 61846474 61867232 61867233 61947557 62352860 62195511 61580837 61638704 61808993 61837768 62159817 62209893 62339997 62352861 61655829 61665436 61665438…
Every code shown here, 1,999 characters
lot no.: 61564135 62126347 61564135R 62251853 62298252 62298252N 61873598 62156174 61846474 61867232 61867233 61947557 62352860 62195511 61580837 61638704 61808993 61837768 62159817 62209893 62339997 62352861 61655829 61665436 61665438 61809036 61864075 61873615 61880354 61943340 61957101 61967998 62076914 62076915 62136636 62154300 62154301 62189392 62240665 62251935 62352862 61817455 61638709 61638710 61864066 61926574 62096972 62240233 62291912 62291912N 61642324 61642325 61627447 61642348 61642355 61867247 61873610 61880350 61880351 61880353 61921684 61923932 61923933 61930395 61953121 61964705 61999747 62188279 62189398 62227006 62234425 62268598 62268603 62285249 62324089 62328956 62285249N 62324089N 62328956N 62060654 62346538 61642326 62251915 61612738 61642361 61642362 61665449 61839045 61840613 61873620 61878443 61884427 61957145 61976123 62060665 62079960 62140524 62165182 62204505 62227010 62234432 62238066 62298271 62309166 62340010 62340011 62340012 62345687 62345690 62309166N 61630550 61803767 61633898 61640799 62105165 62105166 62152061 62152062 62334189 62340015 62346541 62334189N 61840614 61928503 62154514 62203160 61271342 61548278 61661050 61839048 61880361 61884428 61957158 61976135 61976136 62073495 62113213 62143832 62160167 62162433 62178685 62204506 62208743 62218101 62255990 62281822 62340018 62340019 62346543 62346544 62219404 61640807 61941685 62136643 62177334 62240689 62309157 62358865 62363071 62309157N 61813945 61813948 61885848 61873618 61986615 62147323 62154539 62154541 62174599 62188275 62317180 62354677 62354678 62354679 62358863 62358864 62317180N 61921683 62222743 61612718 61837769 61837770 61837771 61964699 62021100 62021101 62140518 62140519 62352868 62358867 62359986 61611815 62079956 62255913 62352869 61532303 61611319 61611320 61612757 61661038 61682017 61839047 61869699 61873623 61976141 61987187 61987188 62060663 62140112 62154304 62162429 62178689 62181416 62193405 62352870 62352871 62358875 62358876 61809012 61952422…
FDA’s list runs to 2,475 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide Distribution
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jan 11, 2016.
- FDA classified it on Mar 12, 2016.
- FDA’s Enforcement Report published it on Mar 23, 2016.
- FDA terminated it on Apr 13, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Zimmer Manufacturing B.V., of Mercedita, PR.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,475 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.