ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer…
Medical device recall Z-0836-2016. 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
- 32537 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?
ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer various sizes These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. “ These devices are indicated for cemented use only. “ The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.”
32537, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Item numbers: 00-5842-011-01 00-5842-011-02 00-5842-012-01 00-5842-012-02 00-5842-013-01 00-5842-013-02 00-5842-014-01 00-5842-014-02 00-5842-015-01 00-5842-015-02 00-5842-016-01 00-5842-016-02 00-5842-017-01 00-5842-017-02 Lot numbers:…
Every code shown here, 1,992 characters
Item numbers: 00-5842-011-01 00-5842-011-02 00-5842-012-01 00-5842-012-02 00-5842-013-01 00-5842-013-02 00-5842-014-01 00-5842-014-02 00-5842-015-01 00-5842-015-02 00-5842-016-01 00-5842-016-02 00-5842-017-01 00-5842-017-02 Lot numbers: 11002504 11002764 11002766 11002767 11002780 11002782 11002784 11003009 11003028 11003042 11003048 11003345 11003366 11003367 11003370 11003371 11003384 11003398 11003399 11003413 11003414 11003433 11003452 11003488 11003490 11003491 11003584 11003587 11003588 11003589 11003603 11003611 11003635 11003642 11003649 11003658 11003659 11003660 11003661 11003689 11003855 11003868 11003878 11003904 11003921 11003944 11003959 11003960 11003974 11004052 11004056 11004074 11004146 11004150 11004152 11004161 11004204 11004306 11004335 11004401 11004402 11004408 11004446 11004450 11004451 11004452 11004455 11004463 11004553 11004563 11004564 11004626 11004677 11004707 11004715 11004720 11004726 11004754 11004790 11004798 11004825 11004830 11004833 11004834 11004851 11004852 11004911 11004912 11004918 11004930 11004986 11004987 11004988 11004993 11005001 11005003 11005031 11005032 11005087 11005090 11005093 11005120 11005121 11005126 11005168 11005194 11005203 11005204 11005214 11005239 11005240 11005242 11005244 11005251 11005349 11005350 11005357 11005414 11005583 11005607 11005608 11005610 11005646 11005749 11005750 11005781 11005800 11005804 11005932 11005938 11005984 11005995 11006023 11006025 11006048 11006060 11006068 11006075 11006145 11006153 11006161 11006162 11006169 11006172 11006200 11006215 11006222 11006223 11006253 11006255 11006271 11006311 11006411 11006439 11006480 11006539 11006550 11006596 11006625 11006715 11006739 11006743 11006751 11006761 11006836 11006884 11006885 11006991 11007049 11007051 11007090 11007212 11007276 11007277 11007311 11007334 11007337 11007439 11007565 11007567 11007584 11007585 11007672 11007854 11007962 11008266 11008315 61774103 61777605 61777607 61777608 61777609 61777610 61777614 61777618…
FDA’s list runs to 14,429 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 14,429 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.