Recall archive / FDA device enforcement
Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0136-S 3.0mm... — FDA record Z-0770-2023
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
- 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
- Reason
- Distribution without Pre-Market Clearance
- Classification
- Class II
- Recalling firm
- Acumed LLC
- Quantity
- 7,498 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0770-2023
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 | 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 10806378028410-477282190808 477323 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-477323190809 500931 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-500931200601 501581 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-501581200610 525006 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-525006210405 525005 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-525005210405 525007 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-525007210405 525102 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-525102210406 525505 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-525505210412 556268 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-556268220222 556269 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-556269220222 556358 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-556358220223 293645 40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028427-293645000000200228 383916 40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028427-383916160608230608 421116 40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028427-421116170906240905 534467 40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028427-534467210709280708 565996 40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028427-565996220615290614 241398 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-241398000000 251500 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-251500000000 273722 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-273722000000 295969 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-295969000000 305610 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-305610000000 320392 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-320392000000 320999 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-320999000000 354105 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-354105000000 360645 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-360645000000 360733 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-360733000000 376553 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-376553000000 380465 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-380465000000 380466 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-380466000000 410223 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-410223170413 410222 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-410222170413 425329 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-425329171030 441811 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-441811180522 441950 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-441950180522 477378 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-477378190812 477519 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-477519190813 501531 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-501531200609 525199 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-525199210407 525200 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-525200210407 555633 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-555633220215 555695 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-555695220216 555694 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-555694220216 293646 40-0137-S 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028441-293646000000200228 422954 40-0137-S 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028441-422954171004241003 477838 40-0137-S 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028441-477838190816260815 515467 40-0137-S 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028441-515467201210271210 534468 40-0137-S 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028441-534468210709280708 570282 40-0137-S 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028441-570282220804290803 237369 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-237369000000 241399 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-241399000000 251501 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-251501000000 295970 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-295970000000 305644 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-305644000000 320393 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-320393000000 361063 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-361063000000 376681 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-376681000000 377214 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-377214000000 380638 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-380638000000 381141 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-381141170717 424465 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-424465171019 424175 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-424175171019 477520 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-477520190813 500956 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-500956200602 525287 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-525287210408 525201 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-525201210407 525288 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-525288210408 556907 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-556907220302 556774 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-556774220228 557543 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-557543220310 556608 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-556608000000 293647 40-0138-S 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028465-293647000000200228 378213 40-0138-S 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028465-378213160322230322 415996 40-0138-S 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028465-415996170627240626 486375 40-0138-S 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028465-486375191203261202 560151 40-0138-S 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028465-560151220403290402 241400 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028472-241400000000 251502 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028472-251502000000 305645 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028472-305645000000 320950 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028472-320950000000 320903 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028472-320903000000 377330 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028472-377330000000 320950A 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028472-320950A170720 423259 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028472-423259171013 423258 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028472-423258171012 525104 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028472-525104210406 525103 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028472-525103210406 554545 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028472-554545220203 554669 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028472-554669220204 554933 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028472-554933220207 293663 40-0139-S 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028489-293663000000200228 402890 40-0139-S 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028489-402890170113240113 469205 40-0139-S 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028489-469205190423260422 534470 40-0139-S 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028489-534470210709280708 570283 40-0139-S 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028489-570283220804290803 237368 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028496-237368000000 241407 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028496-241407000000 251503 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028496-251503000000 320970 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028496-320970000000 320970A 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028496-320970A170630 423354 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028496-423354220103 423579 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028496-423579220103 555104 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028496-555104220208 555184 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028496-555184220209 555183 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028496-555183220209 557309 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028496-557309220308 557310 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028496-557310220308 293664 40-0140-S 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028502-293664000000200228 400322 40-0140-S 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028502-400322161212231212 469203 40-0140-S 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028502-469203190423260422 565999 40-0140-S 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028502-565999220615290614 570284 40-0140-S 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028502-570284220804290803 237370 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 10806378028519-237370000000 241408 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 10806378028519-241408000000 251504 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 10806378028519-251504000000 305469 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 10806378028519-305469000000 361064 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 10806378028519-361064000000 376799 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 10806378028519-376799000000 380044 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 10806378028519-380044170531 380768 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 10806378028519-380768170531 477625 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 1080637... |
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.