Reported Mar 6, 2024 · Ongoing

Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard,…

Acumed LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Acumed LLC · 5885 NW Cornelius Pass Rd · Hillsboro, OR · 97124-9370

Is this the product you have?

Acu-Loc and Acu-Loc 2 bone plates, screws
and accessories for the following REF70-0045 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

Lot codes and dates: All Lots
REF Number /UDI Number
65 of 65 codes
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
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10806378016080-481589191008261007 30-0226-S 10806378016080-481785191009261008 30-0226-S 10806378016080-496248200326270326 30-0226-S 10806378016080-502532200623270623 30-0226-S 10806378016080-516685201230271230 30-0226-S 10806378016080-524769210402280401 30-0226-S 10806378016080-525022210405280404 30-0226-S 10806378016080-546600211025281024 30-0226-S 10806378016080-547124211028281027 30-0226-S 10806378016080-560184220404290403 30-0226-S 10806378016080-560185220404290403 30-0226-S 10806378016080-587474230220300219 30-0226-S 10806378016080-587475230220300219 30-0226-S 10806378016080-587544230221300220 30-0226-S 10806378016080-595769230808300807 30-0226-S 10806378016080-596106230810300809 30-0226-S 10806378016080-596197230814300813 30-0227-S 10806378016097-299971000000200531 30-0227-S 10806378016097-354720000000220531 30-0227-S 10806378016097-362028150831220830 30-0227-S 10806378016097-369465151130221129 30-0227-S 10806378016097-375801160225230224 30-0227-S 10806378016097-386311160715230715 30-0227-S 10806378016097-398924161202231202 30-0227-S 10806378016097-410825170427240426 30-0227-S 10806378016097-437646180322250321 30-0227-S 10806378016097-458763190115260114 30-0227-S 10806378016097-473531190620260619 30-0227-S 10806378016097-492218200217270216 30-0227-S 10806378016097-516727201230271230 30-0227-S 10806378016097-546599211025281024 30-0227-S 10806378016097-547125211028281027 30-0227-S 10806378016097-564872220601290531 30-0227-S 10806378016097-587719230223300222 30-0228-S 10806378016103-299907000000200531 30-0228-S 10806378016103-429422180104250103 30-0228-S 10806378016103-451260181004251003 30-0228-S 10806378016103-465983000000 30-0228-S 10806378016103-469345190425260424 30-0228-S 10806378016103-473532190620260619 30-0228-S 10806378016103-497914200416270416 30-0228-S 10806378016103-502608200624270624 30-0228-S 10806378016103-546848211026281025 30-0229-S 10806378016110-299662000000200531 30-0229-S 10806378016110-299880000000200531 30-0229-S 10806378016110-465044190311260310 30-0229-S 10806378016110-473672190621260620 30-0229-S 10806378016110-498068200420270420 30-0229-S 10806378016110-502609200624270624 30-0229-S 10806378016110-565395220609290608
669 of 669 codes
30-0232
10806378016141-225412000000
30-0232
10806378016141-225048000000
30-0232
10806378016141-238761000000
30-0232
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30-0232
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30-0232
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30-0232
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30-0232
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30-0232
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30-0232
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30-0232
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30-0232
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30-0232
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30-0232
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30-0232
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30-0232
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30-0232
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30-0232
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30-0232
10806378016141-282582000000
30-0232
10806378016141-283335000000
30-0232
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30-0232
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30-0232
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30-0232
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30-0232
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30-0232
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30-0232
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30-0232
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30-0232
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30-0232
10806378016141-297319000000
10806378016158-244873000000180131 30-0232-S 10806378016158-257578000000180831 30-0232-S 10806378016158-318000000000210131 30-0232-S 10806378016158-321625000000210228 30-0232-S 10806378016158-381109160429230429 30-0232-S 10806378016158-386610160708230708 30-0232-S 10806378016158-387044160718230718 30-0232-S 10806378016158-390299160803230803 30-0232-S 10806378016158-399238161128231128 30-0232-S 10806378016158-415983170627240626 30-0232-S 10806378016158-420296170823240822 30-0232-S 10806378016158-422861170929240928 30-0232-S 10806378016158-423707171010241009 30-0232-S 10806378016158-428847171208241207 30-0232-S 10806378016158-432001180112250111 30-0232-S 10806378016158-445404180629250628 30-0232-S 10806378016158-446013180711250712 30-0232-S 10806378016158-460756190121260120 30-0232-S 10806378016158-481748191008261007 30-0232-S 10806378016158-482214191014261013 30-0232-S 10806378016158-489845200117270116 30-0232-S 10806378016158-496048200324270324 30-0232-S 10806378016158-505282200728270728 30-0232-S 10806378016158-512351201027271027 30-0232-S 10806378016158-517692210117280117 30-0232-S 10806378016158-520619210222280222 30-0232-S 10806378016158-527060210427280426 30-0232-S 10806378016158-534703210712280711 30-0232-S 10806378016158-550785211214281213 30-0232-S 10806378016158-550785211214281213 30-0232-S 10806378016158-553322220121290120 30-0232-S 10806378016158-553322220121290120 30-0232-S 10806378016158-557239220303290302 30-0232-S 10806378016158-557239220303290302 30-0232-S 10806378016158-563581220512290511 30-0232-S 10806378016158-563581220512290511 30-0232-S 10806378016158-570040220803290802 30-0232-S 10806378016158-570040220803290802 30-0232-S 10806378016158-573155220917290916 30-0232-S 10806378016158-573155220917290916 30-0232-S 10806378016158-573156220917290916 30-0232-S 10806378016158-573156220917290916 30-0232-S 10806378016158-575057221006291005 30-0232-S 10806378016158-575057221006291005 30-0232-S 10806378016158-575058221006291005 30-0232-S 10806378016158-575058221006291005 30-0232-S 10806378016158-578156221102291101 30-0232-S 10806378016158-578156221102291101 30-0232-S 10806378016158-578157221102291101 30-0232-S 10806378016158-578157221102291101 30-0232-S 10806378016158-581405221212291211 30-0232-S 10806378016158-581405221212291211
388 of 388 codes
30-0233
10806378016165-225489000000
30-0233
10806378016165-225489000000
30-0233
10806378016165-227524000000
30-0233
10806378016165-234094000000
30-0233
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30-0233
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30-0233
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30-0233
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30-0233
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30-0233
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30-0233
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30-0233
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30-0233
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30-0233
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30-0233
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30-0233
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30-0233
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30-0233
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30-0233
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30-0233
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30-0233
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30-0233
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30-0233
10806378016165-250952000000
30-0233
10806378016165-258826000000
30-0233
10806378016165-264093000000
30-0233
10806378016165-265715000000
30-0233
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30-0233
10806378016165-268736000000
30-0233
10806378016165-271131000000
30-0233
10806378016165-274367000000
Amount recalled: 2,952,121 units

Where it was sold

Nationwide
AR
CA
CO
DE
ID
IL
PA
PR

Why it was recalled

Distribution without Pre-Market Clearance

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Medical device recalls

Other recalls from Acumed LLC

9 in total.

Where it was distributed

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