Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm
Medical device recall Z-2794-2015. Published in FDA’s Enforcement Report on Sep 30, 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 Sep 30, 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
- 40038 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?
DLS pin breakage during planned implant removal, after uneventful and successful healing of the fracture. This notice to additional consignees identified after recall Z-0390-2014, related to complaints of breakage located at the bottom of the screws and under the locking screw head.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
40038, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Part Numbers 09.213.022S 09.213.024S 09.213.026S 09.213.028S 09.213.030S 09.213.032S 09.213.034S 09.213.036S 09.213.038S 09.213.040S 09.213.042S 09.213.044S 09.213.046S 09.213.048S 09.213.050S 09.213.052S 09.213.054S 09.213.056S…
Every code shown here, 1,998 characters
Part Numbers 09.213.022S 09.213.024S 09.213.026S 09.213.028S 09.213.030S 09.213.032S 09.213.034S 09.213.036S 09.213.038S 09.213.040S 09.213.042S 09.213.044S 09.213.046S 09.213.048S 09.213.050S 09.213.052S 09.213.054S 09.213.056S 09.213.058S 09.213.060S 09.213.065S 09.213.070S 09.223.032S 09.223.034S 09.223.036S 09.223.038S 09.223.040S 09.223.042S 09.223.044S 09.223.046S 09.223.048S 09.223.050S 09.223.055S 09.223.060S 09.223.065S 09.223.070S 09.223.075S 09.223.080S 09.223.085S 09.223.090S with Lot Numbers 2799588 2799590 2801042 2801043 2802483 2803970 2806031 2809073 2809673 2812544 2813042 2813043 2813065 2814722 2815303 2822441 2822442 7802259 7802261 7804003 7813305 7833918 7883446 2799592 2799804 2801040 2801041 2802484 2803971 2806032 2809075 2809668 2809669 2810870 2810896 2811588 2814723 2815305 2822443 7764728 7769461 7802262 7804004 7804005 7813306 2798572 2798573 2798574 2801019 2803150 2803361 2804799 2809077 2810267 2810268 2814724 2814725 2815307 2815308 2815837 2815838 2815840 2822033 2826534 7801003 7802263 7813307 7824108 7833920 7865322 7913562 8002399 2798708 2801020 2801021 2802485 2803145 2806033 2809078 2809079 2812546 2812547 2813044 2813045 2813770 2818115 2818116 2822034 2822836 2826536 7801004 7813309 7821406 7824110 7833922 7873469 7913565 2798709 2798710 2798711 2801044 2802481 2803151 2809311 2809312 2812548 2812549 2815841 2815842 2815843 2815844 2826537 2826538 7801006 7813311 7824111 7833923 7833926 7913568 7913570 8002411 2798713 2801022 2803152 2803362 2803363 2809313 2809314 2809664 2809665 2812832 2813046 2813047 2813761 2813763 2814733 2815312 2822035 2822036 2826540 7801012 7813313 7824112 7833929 7833930 7873486 2798715 2801023 2803153 2803364 2806034 2806035 2809317 2809318 2813048 2813049 2813064 2813771 2814736 2814738 2815313 2815315 7801017 7804006 7813314 7824113 7833932 7913572 7913578 2798240 2798717 2798718 2798719 2801024 2803365 2806036 2806037 2809666 2809667 2813050 2813063 2813756 2813757 2813766 2814739 2815317…
FDA’s list runs to 8,325 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.
Nationwide Distribution
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 Aug 11, 2015.
- FDA classified it on Sep 18, 2015.
- FDA’s Enforcement Report published it on Sep 30, 2015.
- FDA terminated it on Aug 18, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Synthes (USA) Products LLC, 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 8,325 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.