Product 47 consists of all product under
Medical device recall Z-1145-2016. 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
- 30 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 47 consists of all product under product code: LPH and same usage: Item no: 611004022 MODULAR CUP 10 DEGREE LIN 611004428 MODULAR CUP 10 DEGREE LIN 611004628 MODULAR CUP 10 DEGREE LIN 611004828 MODULAR CUP 10 DEGREE LIN 611004832 MODULAR CUP 10 DEGREE LIN 611005028 MODULAR CUP 10 DEGREE LIN 611005032 MODULAR CUP 10 DEGREE LIN 611005628 MODULAR CUP 10 DEGREE LIN 611005632 MODULAR CUP 10 DEGREE LIN 611005828 MODULAR CUP 10 DEGREE LIN 611005832 MODULAR CUP 10 DEGREE LIN 611006028 MODULAR CUP 10 DEGREE LIN 611006032 MODULAR CUP 10 DEGREE LIN 611006228 MODULAR CUP 10 DEGREE LIN 611006232 MODULAR CUP 10 DEGREE LIN 611006428 MODULAR CUP 10 DEGREE LIN 611006432 MODULAR CUP 10 DEGREE LIN 611006628 MODULAR CUP 10 DEGREE LIN 611006832 MODULAR CUP 10 DEGREE LIN 611007028 MODULAR CUP 10 DEGREE LIN 612004626 MODULAR CUP 20 DEGREE LIN 612004628 MODULAR CUP 20 DEGREE LIN 612004828 MODULAR CUP 20 DEGREE LIN 612004832 MODULAR CUP 20 DEGREE LIN 612005028 MODULAR CUP 20 DEGREE LIN 612005032 MODULAR CUP 20 DEGREE LIN 612005628 MODULAR CUP 20 DEGREE LIN 612005828 MODULAR CUP 20 DEGREE LIN 612005832 MODULAR CUP 20 DEGREE LIN 612006028 MODULAR CUP 20 DEGREE LIN 612006032 MODULAR CUP 20 DEGREE LIN 610504428 MODULAR CUP NEUTRAL LINER 610504832 MODULAR CUP NEUTRAL LINER 610505028 MODULAR CUP NEUTRAL LINER 610505032 MODULAR CUP NEUTRAL LINER 610505632 MODULAR CUP NEUTRAL LINER 610505832 MODULAR CUP NEUTRAL LINER 610506032 MODULAR CUP NEUTRAL LINER 610506232 MODULAR CUP NEUTRAL LINER For use in total hip arthroplasty
30, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
lot no.: 61890322 62213292 62215053 62277522 62402117 61921671 62207256 62212215 62241126 62251893 62268498 62281865 62396132 62402115 62024672 62176459 62210646 62215051 62221907 62241128 62241129 62266480 62277523 62402113 62402114…
Every code shown here, 1,998 characters
lot no.: 61890322 62213292 62215053 62277522 62402117 61921671 62207256 62212215 62241126 62251893 62268498 62281865 62396132 62402115 62024672 62176459 62210646 62215051 62221907 62241128 62241129 62266480 62277523 62402113 62402114 62406796 62202293 62218187 62255246 62281866 62354788 62396145 62406802 61882636 61890326 61942630 61943368 61957706 61957708 61957709 61968019 61983748 61983749 62109144 62109145 62143889 62163554 62173374 62176463 62188368 62197359 62197360 62197361 62204040 62204041 62204042 62204632 62204633 62204634 62207259 62210647 62210648 62213295 62221909 62221910 62226817 62233573 62238101 62241131 62241135 62241136 62241137 62241139 62241142 62241144 62241145 62251896 62251897 62251898 62251899 62251901 62255247 62266481 62266482 62277524 62284060 62352923 62358047 62383751 62383752 62383753 62383754 62386984 62386985 62402212 62402217 61882637 61885966 61889305 61976198 62147389 62170705 62191282 62197358 62199480 62199481 62210649 62210650 62218188 62218189 62218190 62236577 62236578 62241147 62251895 62258978 62260179 62260180 62352924 62358045 62388057 62402126 62402213 61890327 61968020 62170708 62188373 62207257 62207258 62226818 62241149 62241150 62251902 62258976 62268506 62383758 62383759 62396119 62396120 62396121 61980814 62170709 62202294 62202295 62236582 62258974 62260181 62260182 62352926 62358046 62383761 62396133 61976203 62170710 62176464 62191285 62193578 62221912 62226823 62241152 62250619 62251903 62265335 62354787 62396122 62396123 62403713 62406785 61885968 61980816 62167449 62198732 62202296 62218192 62241154 62266483 62354789 62389394 62389395 62402214 61919746 62170712 62207260 62226819 62226820 62251112 62265336 62383760 62402140 62406770 61882639 61980817 62167448 62218193 62266484 62396135 62403714 62406808 61882640 62199479 62233574 62258975 62396149 61980818 62238099 62354790 62402121 62406806 62221914 62402116 62255245 62402122 62268507 62406810 62188377 62258972 62260183 62402118 62183219 62193583 62354791…
FDA’s list runs to 2,438 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 2,438 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.