Recall archive / FDA device enforcement
Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, ... — FDA record Z-1218-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 19, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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;
- Reason
- Distribution without Pre-Market Clearance
- Classification
- Class II
- Recalling firm
- Acumed LLC
- Quantity
- 2,952,121 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1218-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 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10806378016141-282881000000 30-0232 10806378016141-282880000000 30-0232 10806378016141-282581000000 30-0232 10806378016141-282582000000 30-0232 ... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- 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
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Mar 6, 2024
- Recall initiation date
- Dec 19, 2023
- Center classification date
- Feb 29, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.