Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following
Medical device recall Z-1218-2024. Published in FDA’s Enforcement Report on Mar 6, 2024.
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 Mar 6, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 2,952,121 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?
Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Left; 70-0045-S Acu-Loc VDU Plate Standard, Left; 70-0046 Acu-Loc VDU Plate Standard, Right; 70-0046-S Acu-Loc VDU Plate Standard, Right; 70-0047 Acu-Loc VDU Plate Long, Left; 70-0047-S Acu-Loc VDU Plate Long, Left; 70-0048 Acu-Loc VDU Plate Long, Right; 70-0048-S Acu-Loc VDU Plate Long, Right; 70-0055 Acu-Loc Dorsal Plate, Standard, left; 70-0055-S Acu-Loc Dorsal Plate, Standard, left; 70-0056 Acu-Loc Dorsal Plate, Standard, Right; 70-0056-S Acu-Loc Dorsal Plate, Standard, Right; 70-0057 Acu-Loc Dorsal Plate, Narrow, Left; 70-0057-S Acu-Loc Dorsal Plate, Narrow, Left; 70-0058 Acu-Loc Dorsal Plate, Narrow, Right; 70-0058-S Acu-Loc Dorsal Plate, Narrow, Right; 70-0331 Divergent Radial Styloid Plate; 70-0331-S Divergent Radial Styloid Plate; 70-0334 Volar Lunate Suture Plate; 70-0334-S Volar Lunate Suture Plate; 70-0335 Dorsal Rim Buttress Plate, Right; 70-0335-S Dorsal Rim Buttress Plate, Right; 70-0336 Dorsal Rim Buttress Plate, Left; 70-0336-S Dorsal Rim Buttress Plate, Left; 70-0337 Dorsal Lunate Plate, Right; 70-0337-S Dorsal Lunate Plate, Right; 70-0338 Dorsal Lunate Plate, Left;
2,952,121 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
All Lots; REF Number /UDI Number: 30-0100 10806378094637-331500000000 30-0100 10806378094637-342124000000 30-0100 10806378094637-347940000000 30-0100 10806378094637-369580000000 30-0100 10806378094637-379903000000 30-0100…
Every code shown here, 1,977 characters
All Lots; REF Number /UDI Number: 30-0100 10806378094637-331500000000 30-0100 10806378094637-342124000000 30-0100 10806378094637-347940000000 30-0100 10806378094637-369580000000 30-0100 10806378094637-379903000000 30-0100 10806378094637-404624170313 30-0100 10806378094637-414434170728 30-0100 10806378094637-421189171027 30-0100 10806378094637-428663180115 30-0100 10806378094637-438740180329 30-0100 10806378094637-449053180822 30-0100 10806378094637-462420190205 30-0100 10806378094637-476011190723 30-0100 10806378094637-484283191107 30-0100 10806378094637-486858191209 30-0100 10806378094637-489970200120 30-0100 10806378094637-489971200120 30-0100 10806378094637-514064201119 30-0100 10806378094637-526968210426 30-0100 10806378094637-542934210920 30-0100 10806378094637-549407211124 30-0100 10806378094637-559130220324 30-0100 10806378094637-559131220324 30-0100 10806378094637-564636220526 30-0100 10806378094637-564637220526 30-0100 10806378094637-564638220526 30-0100 10806378094637-574209220928 30-0100 10806378094637-574210220928 30-0100 10806378094637-574211220928 30-0100 10806378094637-575356221011 30-0100 10806378094637-331499000000 30-0100 10806378094637-331500A170802 30-0100-S 10806378094644-412714170509240508 30-0100-S 10806378094644-490822200128270127 30-0100-S 10806378094644-564641220526290525 30-0100-S 10806378094644-564642000000 30-0100-S 10806378094644-565035220603290602 30-0100-S 10806378094644-574212220928290927 30-0100-S 10806378094644-574213000000 30-0100-S 10806378094644-574949221005291004 30-0100-S 10806378094644-583160230105300104 30-0218-S 10806378016004-299836000000200531 30-0218-S 10806378016004-300179000000200531 30-0218-S 10806378016004-300180000000200630 30-0218-S 10806378016004-300905000000200731 30-0218-S 10806378016004-379941160428230428 30-0218-S 10806378016004-417738170802240801 30-0218-S 10806378016004-463671190307260306 30-0218-S 10806378016004-485336191119261118 30-0218-S 10806378016004-495321200317270317 30-0218-S…
FDA’s list runs to 1,138,584 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 and the countries of AE, AR, AU, BE, BR, CA, CH, CL, CN, CO, CR, DE, DK, EC, ES, FI, FR, GB, GT, HK, ID, IE, IL, IT, JP, KR, KW, MX, MY, NZ, PA, PE, PR, PT, QA, SA, SE, SG, TH, TR, TW, US, ZA.
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?
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 Dec 19, 2023.
- FDA classified it on Feb 29, 2024.
- FDA’s Enforcement Report published it on Mar 6, 2024.
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.
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 1,138,584 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.