Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6 Total ankle arthroplasty is intended to…
Medical device recall Z-0476-2014. 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
- 265 units (US) 114 units (outside 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 Talar Component Right 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.
265 units (US) 114 units (outside 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 00450002100 62163375 00450002100 62248804 00450002100 62248805 00450002100 62267632 00450002100 62279047 00450002500 62220671 00450002500 62220675 00450002500 62226571 00450002500 62279042 00450002500 62279049…
Every code shown here, 1,997 characters
Part Number Lot Number 00450002100 62163375 00450002100 62248804 00450002100 62248805 00450002100 62267632 00450002100 62279047 00450002500 62220671 00450002500 62220675 00450002500 62226571 00450002500 62279042 00450002500 62279049 00450002500 62285553 00450002500 62290846 00450002500 62290857 00450002500 62343556 00450002500 62357507 00450002500 62368386 00450002500 62375875 00450002500 62405317 00450002500 62409039 00450002500 62419539 00450002500 62428993 00450002500 62439679 00450002500 62442236 00450002600 11007905 00450002600 62163386 00450002600 62262903 00450002600 62264848 00450002600 62290827 00450002600 62297849 00450002100 62287975 00450002100 62331805 00450002100 62337206 00450002100 62337758 00450002100 62349863 00450002100 62357502 00450002100 62358897 00450002100 62397419 00450002100 62397420 00450002200 62163377 00450002200 62239777 00450002200 62239790 00450002200 62267633 00450002200 62267635 00450002200 62279048 00450002200 62279054 00450002200 62290840 00450002200 62290843 00450002200 62337207 00450002200 62343552 00450002200 62357504 00450002200 62375870 00450002200 62405311 00450002200 62416043 00450002200 62419536 00450002200 62453776 00450002200 62453777 00450002200 62459876 00450002300 11009092 00450002300 62163380 00450002300 62215391 00450002300 62215394 00450002300 62220673 00450002300 62267034 00450002300 62267636 00450002300 62279055 00450002300 62285552 00450002300 62305740 00450002300 62310753 00450002300 62323811 00450002300 62337208 00450002300 62337759 00450002300 62349864 00450002300 62357505 00450002300 62357506 00450002300 62372417 00450002300 62375873 00450002300 62378065 00450002300 62409035 00450002300 62409036 00450002300 62416044 00450002300 62419537 00450002300 62453778 00450002400 62163383 00450002400 62208155 00450002400 62239778 00450002400 62267035 00450002400 62267036 00450002400 62267637 00450002400 62267638 00450002400 62297851 00450002400 62305741 00450002400 62305742 00450002400 62310754 00450002400 62316171…
FDA’s list runs to 3,655 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 3,655 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.