AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is intended to treat stable and…
Medical device recall Z-2215-2017. Published in FDA’s Enforcement Report on Jun 7, 2017.
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 7, 2017. 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
- 33,500 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?
nail not properly engaging with the targeting jig due to certain undersized specification
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, interochanteric fractures, high subtrochanteric fractures and combinations of these fractures, including non-union, malunion and tumor resections. The Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas, impending pathological fractures, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal non-unions, malunions, revision procedures and tumor resections.
33,500, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
LOT DLBH21 DLFB60 DLFB61 DLFB62 DLFB63 DLFB64 DLFB65 DLFB66 DLFB67 DLFB68 DLFB69 DLFB6Z DLFB77 DLFB7B DLFB7C DLFB7D DLFB7F DLFB7G DLFB7H DLFB7J DLFB7K DLFB7L DLFB7L DLFB7M DLFB7N DLFB7P DLFB7R DLFB7T DLFB7V DLFB7W DLFB7Y DLFB7Z DLFBB0…
Every code shown here, 2,000 characters
LOT DLBH21 DLFB60 DLFB61 DLFB62 DLFB63 DLFB64 DLFB65 DLFB66 DLFB67 DLFB68 DLFB69 DLFB6Z DLFB77 DLFB7B DLFB7C DLFB7D DLFB7F DLFB7G DLFB7H DLFB7J DLFB7K DLFB7L DLFB7L DLFB7M DLFB7N DLFB7P DLFB7R DLFB7T DLFB7V DLFB7W DLFB7Y DLFB7Z DLFBB0 DLFBB1 DLFBB2 DLFBB3 DLFBB4 DLFBB5 DLFBB6 DLFBB7 DLFBB8 DLFBB9 DLFBBW DLFBBY DLFBBZ DLFBCB DLFBCC DLFBCD DLFBDG DLFBDH DLFBDJ DLFBDJ DLFBDK DLFBDL DLFBDM DLFBDN DLFBDP DLFBDR DLFBDT DLFBDV DLG DLGB70 DLGB71 DLGB72 DLGB73 DLGB74 DLGB75 DLGB76 DLGB77 DLGB78 DLGB79 DLGB7C DLGB7D DLGB7P DLGB7R DLGB7T DLGB7V DLGB7W DLGB7Y DLGB7Z DLGB8 DLGB80 DLGB81 DLGB82 DLGB83 DLGB84 DLGB85 DLGB86 DLGB87 DLGB88 DLGB89 DLGB8B DLGB8C DLGB8D DLGB8F DLGB8G DLGB8H DLGB8J DLGB8K DLGB8L DLGB8M DLGB8N DLGB8P DLGB8R DLGB8R DLGB8T DLGB8V DLGB8W DLGB8Y DLGB8Z DLGB9B DLGB9C DLGB9D DLGB9F DLGB9G DLGB9H DLGB9J DLGB9K DLGB9L DLGB9M DLGB9N DLGBC DLGBC0 DLGBC1 DLGBC3 DLGBC4 DLGBC8 DLGBC9 DLGBCL DLGBCM DLGBCN DLGBCP DLGBCR DLGBCT DLGBCV DLGBCW DLGBCY DLGBCZ DLGBDF DLGBDG DLGBDJ DLGBDK DLGBJ0 DLGBJ1 DLGBJ2 DLGBJ3 DLGBJ4 DLGBJ5 DLGBJ6 DLGBJ7 DLGBJ8 DLGBJ9 DLGBJV DLGBJW DLGBJY DLGBKB DLGBKC DLGBKC DLGBKD DLGBKF DLGBKG DLGBKJ DLGBKK DLGBKL DLGBKM DLGBKN DLGBKP DLGBKR DLGBKT DLGBN4 DLGBN5 DLGBN6 DLGBN7 DLGBNV DLGBPD DLGBPF DLGBPG DLGBPH DLGBPJ DLGBPK DLGBPL DLGBPM DLGBPN DLGBPP DLGBPT DLGBT2 DLGBT3 DLGBT5 DLGBT6 DLGBT8 DLGBT9 DLGBV0 DLGBV1 DLGBV2 DLGBV3 DLGBV4 DLGBV5 DLGBV6 DLGBV7 DLGBV8 DLGBV9 DLGBVB DLGBVC DLGBVD DLGBVF DLGBVG DLGBVH DLGBVJ DLGBVK DLGBVL DLGBVM DLGBVN DLGBVP DLGBVR DLGBVT DLGBVV DLGBVW DLGBVY DLGBVZ DLGBWB DLGBWC DLGBWD DLGBWF DLGBWG DLHB2 DLHB21 DLHB22 DLHB23 DLHB24 DLHB25 DLHB26 DLHB27 DLHB28 DLHB29 DLHB30 DLHB31 DLHB32 DLHB33 DLHB34 DLHB35 DLHB36 DLHB37 DLHB38 DLHB39 DLHB3B DLHB3C DLHB3D DLHB3F DLHB3G DLHB3H DLHB3J DLHB3K DLHB3L DLHB3M DLHB3N DLHB3P DLHB3R DLHB3T DLHB3V DLHB3W DLHB3Y DLHB3Z DLHB40 DLHB41 DLHB42 DLHB43 DLHB44 DLHB45 DLHB46 DLHB47 DLHB4B DLHB4C DLHB4D DLHB4F DLHB4G DLHB4H DLHB4J DLHB4K DLHB4L DLHB4M DLHB4N DLHB4P DLHB4R DLHB4T DLHB4V DLHB4W…
FDA’s list runs to 23,445 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 - US Nationwide and the countries of AUSTRALIA, CANADA, CHILE, COLOMBIA, COSTA RICA, NETHERLANDS, JAPAN, SPAIN AND CANARY ISLANDS, SWITZERLAND and UNITED KINGDOM.
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 17, 2017.
- FDA classified it on Jun 1, 2017.
- FDA’s Enforcement Report published it on Jun 7, 2017.
- FDA terminated it on Aug 6, 2019.
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 23,445 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.