TFN-ADVANCED Proximal Femoral Nailing System (TFNA)
Medical device recall Z-1600-2015. Published in FDA’s Enforcement Report on May 20, 2015.
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 May 20, 2015. 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
- 8175 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?
TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the nail. Potential patient impact: surgical delay.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
8175, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Part Numbers: 04.037.012S 04.037.013S 04.037.014S 04.037.015S 04.037.017S 04.037.019S 04.037.021S 04.037.023S 04.037.025S 04.037.027S 04.037.028S 04.037.029S 04.037.031S 04.037.033S 04.037.035S 04.037.037S 04.037.039S 04.037.042S…
Every code shown here, 1,994 characters
Part Numbers: 04.037.012S 04.037.013S 04.037.014S 04.037.015S 04.037.017S 04.037.019S 04.037.021S 04.037.023S 04.037.025S 04.037.027S 04.037.028S 04.037.029S 04.037.031S 04.037.033S 04.037.035S 04.037.037S 04.037.039S 04.037.042S 04.037.043S 04.037.044S 04.037.045S 04.037.050S 04.037.051S 04.037.052S 04.037.053S 04.037.054S 04.037.055S 04.037.056S 04.037.057S 04.037.058S 04.037.059S 04.037.060S 04.037.061S 04.037.062S 04.037.063S 04.037.064S 04.037.065S 04.037.066S 04.037.067S 04.037.068S 04.037.069S 04.037.112S 04.037.120S 04.037.121S 04.037.123S 04.037.125S 04.037.127S 04.037.129S 04.037.130S 04.037.131S 04.037.133S 04.037.135S 04.037.138S 04.037.142S 04.037.142S 04.037.143S 04.037.144S 04.037.145S 04.037.150S 04.037.151S 04.037.152S 04.037.153S 04.037.154S 04.037.155S 04.037.156S 04.037.157S 04.037.158S 04.037.159S 04.037.160S 04.037.161S 04.037.162S 04.037.163S 04.037.164S 04.037.165S 04.037.166S 04.037.167S 04.037.168S 04.037.169S 04.037.181S 04.037.183S 04.037.185S 04.037.187S 04.037.189S 04.037.193S 04.037.195S 04.037.197S 04.037.199S 04.037.221S 04.037.223S 04.037.224S 04.037.225S 04.037.227S 04.037.229S 04.037.231S 04.037.233S 04.037.235S 04.037.237S 04.037.238S 04.037.239S 04.037.242S 04.037.243S 04.037.244S 04.037.245S 04.037.250S 04.037.251S 04.037.252S 04.037.253S 04.037.254S 04.037.255S 04.037.256S 04.037.257S 04.037.258S 04.037.259S 04.037.260S 04.037.261S 04.037.262S 04.037.263S 04.037.264S 04.037.265S 04.037.267S 04.037.268S 04.037.269S 04.037.451S 04.037.453S 04.037.456S 04.037.457S 04.037.458S 04.037.459S 04.037.460S 04.037.461S 04.037.462S 04.037.463S 04.037.464S 04.037.465S 04.037.466S 04.037.467S 04.037.468S 04.037.469S 04.037.917S 04.037.919S 04.037.921S 04.037.922S 04.037.923S 04.037.927S 04.037.929S 04.037.931S 04.037.933S 04.037.935S 04.037.937S 04.037.939S 04.037.942S 04.037.943S 04.037.944S 04.037.945S 04.037.947S 04.037.949S 04.037.951S 04.037.953S 04.037.954S 04.037.955S 04.037.956S 04.037.957S 04.037.958S 04.037.959S 04.037.961S…
FDA’s list runs to 34,344 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.
Distribution US Nationwide and Switzerland.
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.
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 9, 2015.
- FDA classified it on May 12, 2015.
- FDA’s Enforcement Report published it on May 20, 2015.
- FDA terminated it on Aug 18, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Synthes, Inc., of West Chester, PA.
- 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 34,344 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.