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Medical device recall Z-1056-2018. Published in FDA’s Enforcement Report on Mar 21, 2018.
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 21, 2018. 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
- 13,227 in 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?
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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13,227 in total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
00-5764-013-51 61874481 00-5764-013-51 61892716 00-5764-013-51 61946510 00-5764-013-51 61954552 00-5764-013-51 61977566 00-5764-013-51 62003780 00-5764-013-51 62022335 00-5764-013-51 62029870 00-5764-013-51 62107937 00-5764-013-51 62121782…
Every code shown here, 1,992 characters
00-5764-013-51 61874481 00-5764-013-51 61892716 00-5764-013-51 61946510 00-5764-013-51 61954552 00-5764-013-51 61977566 00-5764-013-51 62003780 00-5764-013-51 62022335 00-5764-013-51 62029870 00-5764-013-51 62107937 00-5764-013-51 62121782 00-5764-013-51 62155687 00-5764-013-51 62159335 00-5764-013-52 61800630 00-5764-013-52 61808793 00-5764-013-52 61819071 00-5764-013-52 61885786 00-5764-013-52 61892717 00-5764-013-52 61914463 00-5764-013-52 61949724 00-5764-013-52 61954981 00-5764-013-52 61977567 00-5764-013-52 62003781 00-5764-013-52 62023325 00-5764-013-52 62030453 00-5764-013-52 62096017 00-5764-013-52 62102077 00-5764-013-52 62127093 00-5764-013-52 62137523 00-5764-013-52 62168360 00-5764-013-52 62169039 00-5764-013-52 62172720 00-5764-013-52 62172721 00-5764-013-52 62173154 00-5764-014-51 61793522 00-5764-014-51 61796450 00-5764-014-51 61802094 00-5764-014-51 61816554 00-5764-014-51 61817772 00-5764-014-51 61817773 00-5764-014-51 11400112 00-5764-014-51 61787880 00-5764-014-51 61829076 00-5764-014-51 61829078 00-5764-014-51 61834863 00-5764-014-51 61835849 00-5764-014-51 61842366 00-5764-014-51 61858497 00-5764-014-51 61868886 00-5764-014-51 61868887 00-5764-014-51 61881032 00-5764-014-51 61881034 00-5764-014-51 61885761 00-5764-014-51 61888051 00-5764-014-51 61892383 00-5764-014-51 61896059 00-5764-014-51 61896058 00-5764-014-51 61897301 00-5764-014-51 61902968 00-5764-014-51 61910188 00-5764-014-51 61914468 00-5764-014-51 61918704 00-5764-014-51 61918705 00-5764-014-51 61924472 00-5764-014-51 61926153 00-5764-014-51 61936817 00-5764-014-51 61943203 00-5764-014-51 61946974 00-5764-014-51 61958271 00-5764-014-51 61958748 00-5764-014-51 61965573 00-5764-014-51 61965574 00-5764-014-51 61967192 00-5764-014-51 61967194 00-5764-014-51 61974066 00-5764-014-51 61974068 00-5764-014-51 61979793 00-5764-014-51 61984251 00-5764-014-51 61986228 00-5764-014-51 61985016 00-5764-014-51 61986231 00-5764-014-51 62017272 00-5764-014-51 62023806 00-5764-014-51 62023333…
FDA’s list runs to 17,495 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: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
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 Nov 29, 2017.
- FDA classified it on Mar 14, 2018.
- FDA’s Enforcement Report published it on Mar 21, 2018.
- FDA terminated it on Apr 2, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Zimmer Biomet, 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 17,495 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.