Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented…
Medical device recall Z-0845-2016. Published in FDA’s Enforcement Report on Mar 2, 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 2, 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
- 72806 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?
LDPE bag containing the implant adheres to the highly polished implant surface.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented various sizes Use of the MultiPolar Bipolar Cup is indicated in: Fracture dislocation of the hip. Elderly, debilitated patients when a total hip replacement is contraindicated. Irreducible fractures in which adequate fixation cannot be obtained. Certain high subcapital fractures and comminuted femoral neck fractures in the aged. Nonunion of femoral neck fractures. Secondary avascular necrosis of the femoral head. Pathological fractures of the femoral neck. Osteoarthritis in which the femoral head is primarily affected.”
72806, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Item numbers: 00-5001-038-00 00-5001-039-00 00-5001-040-00 00-5001-041-00 00-5001-042-00 00-5001-043-00 00-5001-044-00 00-5001-045-00 00-5001-046-00 00-5001-047-00 00-5001-048-00 00-5001-049-00 00-5001-050-00 00-5001-051-00 00-5001-052-00…
Every code shown here, 1,998 characters
Item numbers: 00-5001-038-00 00-5001-039-00 00-5001-040-00 00-5001-041-00 00-5001-042-00 00-5001-043-00 00-5001-044-00 00-5001-045-00 00-5001-046-00 00-5001-047-00 00-5001-048-00 00-5001-049-00 00-5001-050-00 00-5001-051-00 00-5001-052-00 00-5001-053-00 00-5001-054-00 00-5001-055-00 00-5001-057-00 00-5001-058-00 00-5001-060-00 00-5001-062-00 00-5001-064-00 00-5001-066-00 00-5001-068-00 00-5001-070-00 00-5001-072-00 Lot numbers: 00370174 00370176 00370178 00370181 00370453 00370454 00370455 00370457 00370461 00370665 00370751 00370810 00370858 00370859 00370860 00370866 00370867 00370868 00370869 00370870 00370871 00370875 00370893 00370894 00370895 00370908 00370909 00370910 00370911 00370912 00370920 00370924 00370925 00370945 00370946 00370947 00370948 00370949 00370950 00370951 00370952 00370953 00370954 00370986 00370988 61762024 61774923 61774933 61779294 61783774 61783798 61783801 61786883 61786899 61786901 61786902 61786903 61786904 61786905 61786906 61786910 61786911 61786912 61786913 61786915 61786916 61786918 61786921 61786922 61786923 61786924 61786925 61786926 61789197 61790398 61790399 61790400 61790402 61790403 61790406 61790407 61790408 61790409 61790410 61790411 61790413 61790414 61795021 61795024 61795025 61795026 61795027 61795028 61795029 61795030 61795031 61795032 61795033 61795034 61795035 61795036 61795037 61795038 61795039 61795040 61798106 61798107 61798108 61798109 61798110 61798111 61798112 61798113 61798114 61798115 61798116 61798117 61798118 61798119 61798120 61798121 61798122 61798123 61798124 61798125 61798126 61798127 61798684 61798685 61798686 61798687 61798689 61798690 61798691 61798692 61798693 61798694 61798695 61798696 61798697 61798698 61798699 61798701 61802418 61802419 61802420 61802422 61802423 61802424 61802425 61802426 61802427 61803796 61803797 61803798 61803799 61803801 61803802 61803803 61803804 61803805 61803806 61803807 61803808 61803809 61803810 61803811 61803812 61803813 61803814 61803815 61803816 61803817 61803818…
FDA’s list runs to 28,340 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 Internationally to ARGENTINA AUSTRALIA AUSTRIA BARBADOS BELGIUM BERMUDA BOLIVIA BRAZIL CARIBBEAN CHILE CHINA COLOMBIA COST RICA DENMARK DOMINICAN REPUBLIC DORAL FL ECUADOR EL SALVADOR ENGLAND FRANCE GERMANY GUATEMALA HONDURAS HONG KONG INDIA ISRAEL ITALY JAMAICA JAPAN KOREA MALAYSIA MEXICO NEW ZEALAND NICARAGUA PANAMA PERU SINGAPORE SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND VENEZUELA WEST INDIES Canary Islands Croatia Cyprus Czech Republic Canada
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 Jan 11, 2016.
- FDA classified it on Feb 22, 2016.
- FDA’s Enforcement Report published it on Mar 2, 2016.
- FDA terminated it on May 23, 2017.
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 28,340 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.