Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous,…
Medical device recall Z-0837-2016. 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
- 5103 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?
Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes “ Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation). History of patellar dislocation or patella fracture. Dysplasia-induced degeneration. This device is intended for cemented use only.”
5103, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Item numbers: 00-5926-011-01 00-5926-011-02 00-5926-012-01 00-5926-012-02 00-5926-013-01 00-5926-013-02 00-5926-014-01 00-5926-014-02 00-5926-015-01 00-5926-015-02 Lot numbers: 11003385 11003487 11003827 11003957 11004055 11004100 11004102…
Every code shown here, 1,995 characters
Item numbers: 00-5926-011-01 00-5926-011-02 00-5926-012-01 00-5926-012-02 00-5926-013-01 00-5926-013-02 00-5926-014-01 00-5926-014-02 00-5926-015-01 00-5926-015-02 Lot numbers: 11003385 11003487 11003827 11003957 11004055 11004100 11004102 11004106 11004145 11004378 11004444 11004449 11004454 11004464 11004499 11005712 11005779 11005783 11006058 11006623 11006851 11006878 11006925 11006973 11008245 11008259 11008270 11008331 11008381 61771793 61771795 61777453 61777454 61777455 61777456 61777457 61782636 61782637 61782638 61782639 61782640 61782641 61782642 61788821 61788822 61788823 61788824 61788825 61788826 61788827 61795693 61795694 61795695 61795696 61795697 61795698 61801039 61801040 61801041 61801042 61801043 61801044 61805590 61805591 61805592 61805593 61805594 61805595 61809895 61809897 61809898 61809899 61809901 61809902 61815366 61815367 61815368 61815369 61815370 61815371 61822252 61822253 61822254 61822255 61822256 61822257 61822258 61822259 61824055 61824056 61824057 61824058 61824059 61824060 61824061 61830909 61830910 61830911 61830912 61830913 61830914 61830915 61836415 61836416 61836417 61836418 61836419 61836420 61846210 61846211 61846212 61846213 61846214 61846215 61846216 61848468 61848469 61848470 61848471 61848472 61848473 61848474 61853892 61853893 61853896 61853897 61853898 61853899 61853901 61857280 61857281 61857282 61857283 61857284 61857286 61857287 61861620 61861621 61861622 61861623 61861624 61861625 61861626 61866469 61866470 61866471 61866472 61866473 61866474 61866475 61871356 61871357 61871358 61871359 61871360 61871361 61871362 61871854 61871855 61871856 61871857 61871858 61871859 61871860 61876121 61876122 61876123 61876124 61876125 61885074 61885075 61885076 61885077 61885078 61885079 61889296 61889297 61889298 61889301 61889302 61889303 61894348 61894349 61894350 61894351 61894352 61894353 61899464 61899465 61899466 61899467 61899468 61899469 61904075 61904076 61904077 61904078 61904079 61904080 61910479 61910480 61910481…
FDA’s list runs to 4,964 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 4,964 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.