Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6 Total ankle arthroplasty is intended to…
Medical device recall Z-0477-2014. Published in FDA’s Enforcement Report on Dec 18, 2013.
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 Dec 18, 2013. 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
- 390 units (US) 129 units (outside of US) 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?
As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing elevated levels of manufacturing materials residue on the implants. The specific material was found to be mass media utilized during the manufacturing process to provide the uniform surface finish. This mass media
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with: “ Rheumatoid arthritis. “ Post-traumatic arthritis. “ Degenerative arthritis. This device is intended for cemented use only.
390 units (US) 129 units (outside of US), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Part Number Lot Number 00450004100 62143211 00450004100 62215399 00450004100 62226572 00450004100 62239797 00450004100 62248808 00450004100 62285639 00450004100 62290853 00450004200 62143212 00450004200 62208157 00450004200 62208158…
Every code shown here, 1,997 characters
Part Number Lot Number 00450004100 62143211 00450004100 62215399 00450004100 62226572 00450004100 62239797 00450004100 62248808 00450004100 62285639 00450004100 62290853 00450004200 62143212 00450004200 62208157 00450004200 62208158 00450004200 62215401 00450004200 62220683 00450004200 62226573 00450004200 62248809 00450004200 62267650 00450004200 62285554 00450004200 62299545 00450004200 62393808 00450004200 62416048 00450004200 62419541 00450004300 62143213 00450004300 62160229 00450004300 62208159 00450004300 62215402 00450004300 62220681 00450004300 62220684 00450004300 62267645 00450004300 62279057 00450004300 62285555 00450004300 62285556 00450004300 62305745 00450004300 62305746 00450004300 62310757 00450004300 62349877 00450004300 62357515 00450004300 62368389 00450004300 62378070 00450004300 62397422 00450004300 62409042 00450004300 62416049 00450004300 62419542 00450004300 62442239 00450004300 62453785 00450004400 62168364 00450004400 62208160 00450004400 62215403 00450004400 62220686 00450004400 62232378 00450004400 62267647 00450004400 62297853 00450004400 62299546 00450004400 62299547 00450004400 62299548 00450004400 62343569 00450004400 62349879 00450004400 62372420 00450004400 62393809 00450004400 62397423 00450004400 62405323 00450004400 62409043 00450004500 62143215 00450004500 62215404 00450004500 62220688 00450004500 62232379 00450004500 62248810 00450004500 62254967 00450004500 62279058 00450004500 62299549 00450004500 62368390 00450004500 62378071 00450004600 62143216 00450004600 62239795 00450004600 62239796 00450004600 62248811 00450004600 62254968 00450004600 62285640 00450004600 62290855 00450004600 62405325 00830004100 62208152 00830004100 62316180 00830004100 62363978 00830004200 62204737 00830004200 62226574 00830004200 62239798 00830004200 62316181 00830004200 62337230 00830004200 62375878 00830004300 62204736 00830004300 62226575 00830004300 62232380 00830004300 62297854 00830004300 62323804 00830004300 62343570 00830004300 62372421…
FDA’s list runs to 2,332 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 - USA (nationwide) and Internationally to Australia, Canada, China, Finland, Germany, and Italy.
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 12, 2013.
- FDA classified it on Dec 10, 2013.
- FDA’s Enforcement Report published it on Dec 18, 2013.
- FDA terminated it on Oct 15, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Zimmer, Inc., of Warsaw, IN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
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 2,332 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.