Bipolar liners and Multipolar cups with the following dimensions in MM
Medical device recall Z-1019-2014. Published in FDA’s Enforcement Report on Feb 26, 2014.
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 Feb 26, 2014. 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
- 7,044,680 total 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?
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Bipolar liners and Multipolar cups with the following dimensions in MM (38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 53, 54, 55, 57, 58, 60, 64, 66, 68, 70, 72) and several OD
7,044,680 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
369276 369524 60291473 60310301 60342024 60357090 60399558 60425903 60452829 60558758 60570479 60584084 60590812 60599272 60611906 60620113 60657785 60682169 60687824 60708283 60711104 60821371 60841560 60907093 60984963 61022804 61070950…
Every code shown here, 2,000 characters
369276 369524 60291473 60310301 60342024 60357090 60399558 60425903 60452829 60558758 60570479 60584084 60590812 60599272 60611906 60620113 60657785 60682169 60687824 60708283 60711104 60821371 60841560 60907093 60984963 61022804 61070950 61077603 61134756 61154119 61175581 61209547 61228859 61270001 61287201 61368475 61368477 61530412 61533227 61533467 61692052 61732327 61774928 61783774 61824402 61870194 61873807 61879216 61910402 61977973 62063907 62075334 62106829 62146121 62150826 62240863 62291985 60563149 60566878 60600179 60630361 60815719 60828775 61066145 61144414 61162703 61213636 61261189 61313751 61408337 61461416 61504803 61522363 61756178 61783396 61847265 61923132 61998438 62133204 62298309 369341 370194 60222129 60353227 60368431 60373709 60399559 60466343 60507563 60554703 60579220 60584085 60599273 60623449 60656522 60661145 60662839 60687825 60708286 60709627 60709632 60711101 60841591 60867231 60884747 60976986 60976987 61008062 61036699 61070953 61115030 61135548 61135550 61175582 61200729 61200730 61260738 61279518 61283870 61283871 61345873 61382663 61401473 61453030 61504719 61549273 61549274 61549275 61549276 61677022 61692027 61722491 61742558 61779295 61810839 61824403 61859392 61882807 61887464 61895659 61977974 61993270 62002515 62118749 62148588 62183205 62262698 62291986 60581741 60581742 60612133 60643129 60670842 60885034 61006076 61017248 61135870 61151284 61151285 61162712 61191580 61191582 61213637 61296090 61313753 61388431 61408356 61461420 61554436 61695657 61728055 61751742 61803721 61847257 61899761 61985050 62046280 62103973 62182475 62275050 62311689 369521 370193 370858 370945 60222133 60266021 60291474 60310305 60325143 60325144 60333414 60342026 60353228 60357681 60361328 60368433 60383211 60392168 60392169 60421527 60439918 60439919 60452834 60452835 60472566 60499470 60507564 60515205 60537020 60557545 60563123 60575106 60581719 60584086 60595310 60599274 60611914 60630347 60630619 60643072 60643073 60656529 60661146…
FDA’s list runs to 103,468 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.
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.
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.
The words say it went outside the United States too.
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 Oct 11, 2013.
- FDA classified it on Feb 20, 2014.
- FDA’s Enforcement Report published it on Feb 26, 2014.
- FDA terminated it on Apr 14, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Zimmer, Inc., of Warsaw, IN.
- 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 103,468 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
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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.