Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and…
Medical device recall Z-1236-2018. Published in FDA’s Enforcement Report on Apr 4, 2018.
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 Apr 4, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 38 states named
- 2470 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?
Certain lots of the Phoenix Tibia Nail 3.5mm Inserter instruments are being recalled due to reports of fracturing and remaining in the device implant.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Numbers: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S, 14-444000-00, 979105, 14-441045-00, and 14-444000S
2470, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lots manufactured before March 30, 2017. Packaging Lot Numbers: 303420 301890 507880 507930 507980 508010 508020 508030 508070 508080 484940 485380 485410 485420 485430 485440 485450 485460 535050 623990 636950 636960 636970 636980 636990…
Every code shown here, 2,000 characters
Lots manufactured before March 30, 2017. Packaging Lot Numbers: 303420 301890 507880 507930 507980 508010 508020 508030 508070 508080 484940 485380 485410 485420 485430 485440 485450 485460 535050 623990 636950 636960 636970 636980 636990 676570 676600 676610 676620 676630 676640 928320 928340 928370 928380 090570 484120 484230 484300 484320 484330 484370 484420 484440 484450 484490 526200 526210 526230 526250 526260 526270 526280 526290 526300 598480 599230 599240 599250 599260 599270 658950 658980 658990 659000 659010 659020 676710 677010 677030 677040 697990 698710 721000 721360 721380 721390 721400 721410 721420 721440 625110 079640 508410 508450 508460 508470 508480 508490 508510 508520 508500 457030 073530 073540 073550 073560 073570 073580 073590 073600 073610 627490 656470 656580 656590 656600 656610 656620 656640 656660 966880 967050 967060 967070 980260 980270 079630 008370 008380 008390 008400 008410 091030 091060 091070 091080 980300 980320 980330 980340 980350 987180 101450 101480 111700 111760 116820 118330 142400 149540 164240 190740 201170 210470 216850 243350 268070 276080 280600 280610 302860 306510 306520 327060 327070 327310 327450 334390 335080 335090 335400 335860 336050 336590 337680 350280 395470 410060 413360 468260 491750 496810 510290 512200 527380 527390 527400 527410 527420 527430 531370 537580 537690 540340 557600 561800 573000 573010 573020 578820 579370 609980 629790 663130 665910 671300 677620 700420 783690 804170 809490 812420 812480 812490 834860 885960 916980 983220 996210 013740 031700 034530 035820 053600 079000 094440 116670 148490 232080 233850 289870 371460 384950 442070 482990 483000 523880 532610 533130 545110 571850 586840 625100 625120 662930 815370 842080 852840 861160 881130 956490 973560 983600; Laser marking on the device: 90225701 RS08A014 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192 90227192…
FDA’s list runs to 4,127 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: US (nationwide) AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico; and countries of: Australia, Brazil, Canada, Chile, Colombia, El Salvador, Netherlands, Japan, Costa Rica, Spain, and Thailand.
The states and territories these words name
38 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Montana
- North Carolina
- New Jersey
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
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 Mar 12, 2018.
- FDA classified it on Apr 6, 2018.
- FDA’s Enforcement Report published it on Apr 4, 2018.
- FDA terminated it on Nov 18, 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: 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 4,127 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.