Dual-Trak Clavicle Screws
Medical device recall Z-0770-2023. Published in FDA’s Enforcement Report on Jan 4, 2023.
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 Jan 4, 2023. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 52 states named
- 7,498 units 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?
Distribution without Pre-Market Clearance
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0137-S 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 40-0138-S 3.0mm x 100mm Dual-Trak Clavicle Screw 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 40-0139-S 3.0mm x 110mm Dual-Trak Clavicle Screw 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 40-0140-S 3.0mm x 120mm Dual-Trak Clavicle Screw 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 40-0143-S 3.8mm x 80mm Dual-Trak Clavicle Screw 40-0144 3.8mm x 90mm Dual-Trak Clavicle Screw 40-0144-S 3.8mm x 90mm Dual-Trak Clavicle Screw 40-0145 3.8mm x 100mm Dual-Trak Clavicle Screw 40-0145-S 3.8mm x 100mm Dual-Trak Clavicle Screw 40-0146 3.8mm x 110mm Dual-Trak Clavicle Screw 40-0146-S 3.8mm x 110mm Dual-Trak Clavicle Screw 40-0147 3.8mm x 120mm Dual-Trak Clavicle Screw 40-0147-S 3.8mm x 120mm Dual-Trak Clavicle Screw
7,498 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Dual-Trak Clavicle Screws: Batch Number/Part Number/Part Description/UDI Code: 237352 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-237352000000 241396 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw…
Every code shown here, 1,995 characters
Dual-Trak Clavicle Screws: Batch Number/Part Number/Part Description/UDI Code: 237352 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-237352000000 241396 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-241396000000 251499 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-251499000000 273721 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-273721000000 295968 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-295968000000 305419 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-305419000000 320123 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-320123000000 320365 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-320365000000 320998 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-320998000000 353959 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-353959000000 360734 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-360734000000 361151 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-361151000000 376436 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-376436000000 377113 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-377113000000 379009 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-379009000000 379939 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-379939000000 379920 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-379920000000 410141 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-410141170413 410142 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-410142170413 423108 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-423108171009 423212 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-423212171009 441951 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-441951180523 442003 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-442003180524 477282 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw…
FDA’s list runs to 19,075 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 - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, and WY. The countries of AE, AR, AU, BE, BR, CA, CH, CL, CN, CO, CR, DE, DK, EC, ES, FI, FR, GB, GT, HK, IE, IL, IT, JP, KR, KW, MX, MY, PA, PE, PR, PT, QA, SA, SE, SG, TH, TR, TW, and ZA.
The states and territories these words name
52 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- US Virgin Islands
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 29, 2022.
- FDA classified it on Dec 23, 2022.
- FDA’s Enforcement Report published it on Jan 4, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Acumed LLC, of Hillsboro, OR.
- 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 19,075 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
-
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.