POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 00587806535 POROUS PATELLA 38MM X 10MM -…
Medical device recall Z-1950-2016. Published in FDA’s Enforcement Report on Jun 22, 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 Jun 22, 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
- 19,884 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 Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 00587806535 POROUS PATELLA 38MM X 10MM - 00587806538 POROUS PATELLA 41MM X 10MM - 00587806541
19,884 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
POROUS PATELLA 32MM X 10MM 61728647 61762587 62028703 62082384 61998061 61728648 61781040 62028701 62082387 61998065 61762578 61781037 62028702 62100771 62003279 61762581 61781039 62028705 62100774 62003280 61762584 61796452 62051894…
Every code shown here, 1,998 characters
POROUS PATELLA 32MM X 10MM 61728647 61762587 62028703 62082384 61998061 61728648 61781040 62028701 62082387 61998065 61762578 61781037 62028702 62100771 62003279 61762581 61781039 62028705 62100774 62003280 61762584 61796452 62051894 62100773 61998062 61762585 61796458 62051896 62100775 61998064 61770640 61770641 62051895 62100777 62003281 61770642 61796459 62109088 62109087 62003282 61762579 61781036 62109089 62100768 62003283 61762580 61770638 62100770 62100769 62007635 61762582 61781038 62109090 62100772 62007636 61762583 61796451 62119906 62100776 61874756 61770639 61796460 62119907 62109086 61874758 61890052 61910583 61890055 61914846 61878840 61890053 61910584 61890054 61914845 61878841 61890056 61896662 61910581 61830190 61878844 61844395 61890050 61910582 61830189 61890058 61914849 61830191 61844393 62007641 62082386 61914848 61850552 61850551 62022120 62082388 61946320 61874757 61850549 62022121 62082383 61952743 61878842 61850553 62022123 62082379 61977124 61878843 61890057 62028698 62082381 61977125 61762586 61830192 62119909 62119910 61977130 61796453 61834679 62082385 62119908 61977123 61796455 61834680 62007643 61986196 61977129 61796456 61834681 62009518 61998059 61986193 61796454 61834682 62016304 62051893 61986194 61796457 61834683 62007642 62051890 61896664 61807383 61840029 62016301 62051891 61890051 61814825 61840032 62016303 62051892 61896660 61807384 61840031 62007637 62051897 61896661 61814823 61840030 62007640 62051898 61896663 61814824 61840033 62007644 62051899 61910585 61818410 61844394 62016305 62082380 62016306 61844396 62009517 61914847 62082382 POROUS PATELLA 35MM X 10MM 61722891 61722891 61752727 61752729 61752730 61752728 61762601 61770637 61762596 61762603 61762599 61762602 61776851 61776852 61762597 61762604 61781047 61781046 61796468 61776850 61796465 61796466 61776853 61796467 61796464 61796469 61807385 61818413 61807386 61814827 61818412 61807387 61830194 61830202 61830195 61834685 61834684 61834686 61840037 61840039 61844360…
FDA’s list runs to 3,707 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.
Nationwide and Foreign.
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 Apr 15, 2016.
- FDA classified it on Jun 10, 2016.
- FDA’s Enforcement Report published it on Jun 22, 2016.
- FDA terminated it on Nov 29, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Zimmer Trabecular Metal Technology, Inc., of Parsippany, NJ.
- 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 3,707 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.