Recall archive / FDA device enforcement
AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw ... — FDA record Z-0769-2023
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 Nov 29, 2022. 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
- AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw AI-0020 20mm AcuTwist¿ Acutrak Compression Screw AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw AI-0026 26mm AcuTwist¿ Acutrak Compression Screw AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw AI-0030 30mm AcuTwist¿ Acutrak Compression Screw AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw
- Reason
- Distribution without Pre-Market Clearance
- Classification
- Class II
- Recalling firm
- Acumed LLC
- Quantity
- 80,805 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0769-2023
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 | AcuTwist Acutrak Compression Device Batch Number/Part Number/Part Description/UDI Code: 204010 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-204010000000160531 219050 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-219050000000170130 226652 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-226652000000170531 236972 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-236972000000171231 239079 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-239079000000180131 260403 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-260403000000181231 265390 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-265390000000190228 270950 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-270950000000190331 273603 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-273603000000190731 278305 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-278305000000190930 358993 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-358993000000220731 358079 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-358079150903220902 404026 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-404026170131240131 411204 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-411204170418240417 412910 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-412910170728240727 417672 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-417672170721240720 433231 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-433231180125250124 440500 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-440500180430250429 427818 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-427818180604250603 444129 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-444129181005251004 453386 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-453386181018251017 453539 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-453539181130251129 459459 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-459459190114260113 459372 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-459372190319260318 459459A AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-459459A190114260113 207543 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-207543000000160630 221773 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-221773000000170330 232103 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-232103000000170930 239090 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-239090000000180228 252663 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-252663000000180731 261805 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-261805000000190131 265385 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-265385000000190331 270951 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-270951000000190331 273604 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-273604000000190731 276600 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-276600000000190831 283677 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-283677000000191231 301351 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-301351000000200831 334669 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-334669000000211130 355218 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-355218150903220902 369265 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-369265160209230208 376423 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-376423160303230303 387265 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-387265161003231003 411897 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-411897170724240723 417673 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-417673170721240720 433232 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-433232180125250124 440501 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-440501180430250429 426684 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-426684180531250530 444012 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-444012180612250611 453387 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-453387181018251017 453540 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-453540181205251204 459460 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-459460190114260113 459373 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-459373190111260110 468010 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-468010190411260410 492287 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-492287200217270216 509415 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-509415200922270922 554972 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-554972220207290206 554972A AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-554972A220207290206 204011 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-204011000000160630 218592 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-218592000000161231 224771 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-224771000000170531 233064 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-233064000000171030 239085 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-239085000000180228 252664 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-252664000000180731 260404 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-260404000000181231 264920 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-264920000000190228 270952 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-270952000000190331 273605 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-273605000000190731 276601 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-276601000000190831 283678 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-283678000000191231 310758 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-310758000000201231 341293 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-341293000000220228 358994 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-358994000000220731 365605 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-365605151204221203 395810 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-395810161014231014 403328 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-403328170306240305 422718 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-422718180110250109 430350 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-430350171228241227 433234 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-433234180125250124 440502 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-440502180430250429 428302 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-428302180529250528 453388 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-453388181018251017 453541 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-453541181205251204 459461 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-459461190114260113 459374 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-459374190111260110 492288 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-492288200217270216 453541A AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-453541A181205251204 541180 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-541180210907280906 541180A AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-541180A210907280906 202127 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-202127000000160331 207544 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-207544000000160730 219051 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-219051000000170130 221774 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-221774000000170330 228560 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-228560000000170630 236973 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-236973000000171231 239086 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-239086000000180228 255718 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-255718000000180930 263764 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-263764130131190131 270953 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-270953000000190331 267149 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-267149000000190430 278306 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-278306130930190930 293298 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-293298000000200430 326969 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-326969000000210731 349764 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-349764000000220630 358995 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-358995000000220731 369262 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-369262160218230217 398310 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-398310170106240106 423537 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-423537180109250108 430351 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-430351171227241226 433233 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-433233180125250124 440503 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-440503180430250429 453390 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-453390181018251017 453542 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-453542181130251129 430022 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-430022171213241212 455496 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-455496181116251115 459375 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-459375190111260110 468011 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-468011190411260410 468011A AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-468011A190411260410 430022A AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-430022A171213241212 537368 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-537368210806280805 537368A AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-537368A210806280805 200695 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-200695000000160331 208829 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-208829000000160730 219175 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-219175000000170131 220153 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-220153000000170131 225031 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-225031000000170531 236002 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-236002000000171231 239089 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-239089000000180228 252665 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-252665000000180731 260405 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-260405000000181231 266045 AI-0018-S 18mm AcuTw... |
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 - 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.
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
- Jan 4, 2023
- Recall initiation date
- Nov 29, 2022
- Center classification date
- Dec 23, 2022
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.