Product 23 consists of all
Medical device recall Z-1121-2016. 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
- 10 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 23 consists of all product code: JDI and same usage: Item no: 801100220 CPT 2 HIP STEM, X-OFFSET 801100320 CPT 3 HIP STEM, X-OFFSET 801100420 CPT 4 HIP STEM, X-OFFSET 801100005 CPT HIP STEM PETITE 801100700 CPT HIP STEM SZ 2 LONG 801100800 CPT HIP STEM SZ 3 LONG 801100222 CPT MOD HD ST/ST 22MED SH 801100322 CPT MOD HD ST/ST 22MMD LN 801100122 CPT MOD HD ST/ST 22MMD SH 801100126 CPT MOD HD ST/ST 26MMD SH 801100328 CPT MOD HD ST/ST 28MMD LN 801100228 CPT MOD HD ST/ST 28MMD ME 801100128 CPT MOD HD ST/ST 28MMD SH 801100332 CPT MOD HD ST/ST 32MMD LN 801100232 CPT MOD HD ST/ST 32MMD ME 801100132 CPT MOD HD ST/ST 32MMD SH 801100100 CPT MODULAR STEM SIZE 1 S 801100200 CPT MODULAR STEM SIZE 2 S 801100300 CPT MODULAR STEM SIZE 3 S 801100400 CPT MODULAR STEM SIZE 4 S 801100500 CPT MODULAR STEM SIZE 5 S For use in total or hemi hip arthroplasty
10, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
lot no.: 61882616 62030937 62087634 62154310 62264269 62312479 62264269N 62033232 62097081 62264270 62303492 62097082 62264271 62324103 62264271N 61833317 61936207 61942441 61955618 61964737 62024630 62024632 62028824 62028826 62028827…
Every code shown here, 1,993 characters
lot no.: 61882616 62030937 62087634 62154310 62264269 62312479 62264269N 62033232 62097081 62264270 62303492 62097082 62264271 62324103 62264271N 61833317 61936207 61942441 61955618 61964737 62024630 62024632 62028824 62028826 62028827 62028828 62041514 62041515 62041516 62042594 62042595 62043475 62094958 62094959 62103574 62103575 62105196 62105197 62106789 62118981 62121273 62121274 62122111 62148550 62148551 62240713 62249029 62255999 62284453 62094958N 62094959N 62103574N 62105196N 62105197N 62118981N 62121273N 62121274N 62122111N 62148550N 62148551N 62249029N 62255999N 62284453N 62065267 62097089 62161471 62303493 62332024 62332024N 61907672 62069520 62161473 62227021 62161473N 62227021N 61653623 61951328 62054833 62089761 62327042 62332620 62362980 62399487 62089761N 62089763 62404691 62089763N 62075382 62086078 62377682 62399485 62075382N 62086078N 62396944 60728070N 62396944V 61593599 61593603 61636319 61636320 61636321 61636323 62065349 62197304 62268534 62268535 62270745 62299141 62299142 62299144 62312516 62318744 62320124 62320125 62326145 62329082 62330793 62330794 62332318 62332319 62332320 62360010 62370903 62376915 62376916 62377681 62389961 62389962 62389963 62397791 62332319N 62332320N 61555369 61636314 61899105 61951332 62065347 62154347 62197301 62197302 62197303 62204571 62204575 62210476 62263548 62263549 62263550 62273047 62276477 62301480 62301481 62301482 62305971 62305972 62305973 62305974 62325598 62326143 62329081 62330792 62352873 62352874 62352875 62352876 62360016 62360017 62362969 62362971 62362972 62370898 62370899 62370905 62370906 62370908 62371744 62371745 62263550N 62325598N 62326143N 62330792N 61951327 61957503 62096318 62197308 62212014 62263546 62305975 62317883 62319763 62320127 62360012 62370902 62389964 62399490 62263553 62263554 62308236 62327043 61839080 62167396 62197306 62212015 62263551 62302038 62308234 62315647 62327044 61609809 61882646 62319762 62354798 61837753 61873657 61884443 61884444 61884445 61896760…
FDA’s list runs to 3,970 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 3,970 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.