Reported Apr 1, 2026 · Ongoing

Brand Name

I.T.S. GmbH

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: I.T.S. GmbH · Autal 28 · Lasnitzhohe · N/A

Is this the product you have?

Brand Name

20 of 20 products

Products covered by this recall
#Product as published
1Anterior Column Plate; Article Numbers: 21218-16, 21219-16.
2Anterior Column Plate; Article Numbers: 21218-14, 21219-14.
3Biplanar 2-Column Plate; Article Numbers: 21216-10, 21216-12, 21217-10, 21217-12.
4Cancellous Screw; Article Numbers: 30591-36, 30591-70, 30591-75, 30591-80, 30591-85, 30591-90.
5Cancellous Screw, Locking; Article Numbers: 37422-12-N, 37422-14-N, 37422-16-N, 37422-18-N, 37422-20-N, 37422-22-N, 37422-24-N, 37422-26-N, 37422-28-N, 37422-30-N, 37422-32-N, 37422-34-N, 37422-36-N, 37422-38-N, 37422-40-N, 37422-42-N, 37422-44-N, 37422-46-N, 37422-48-N, 37422-50-N, 37422-55-N, 37422-60-N, 37422-65-N, 37422-70-N, 37422-75-N, 37422-80-N, 37422-85-N, 37422-90-N, 37422-95-N, 37422-100-N, 37422-105-N, 37422-110-N, 37422-115-N, 37422-120-N, 37592-18, 37592-20, 37592-22, 37592-24, 37592-26, 37592-28, 37592-30, 37592-32, 37592-34, 37592-36, 37592-38, 37592-40, 37592-42, 37592-46, 37592-48, 37592-50, 37592-54, 37592-56, 37592-58, 37592-60, 37592-65, 37592-70, 37592-75, 37592-80, 37592-85, 37592-90.
6Cannulated Screw, Cancellous; Article Numbers: 31851-60, 31851-65, 31851-70, 31851-75, 31851-80, 31851-85, 31851-90, 31851-95, 31851-100, 31851-105, 31851-110, 31851-115, 31851-120, 31851-125, 31851-130, 31851-135, 31851-140, 31851-145, 31851-150, 31851-155, 31851-160, 31851-165, 31851-170, 31851-175, 31851-180, 31851-185, 31851-190, 31851-195, 31851-200, 31854-60, 31854-65, 31854-70, 31854-75, 31854-80, 31854-85, 31854-90, 31854-95, 31854-100, 31854-105, 31854-110, 31854-115, 31854-120, 31854-125, 31854-130, 31854-135, 31854-140, 31854-145, 31854-150, 31854-155, 31854-160, 31854-165, 31854-170, 31854-175, 31854-180, 31854-185, 31854-190, 31854-195, 31854-200.
7Cortical Screw; Article Numbers: 32351-10, 32351-12, 32351-14, 32351-16, 32351-18, 32351-20, 32351-22, 32351-24, 32351-26, 32351-28, 32351-30, 32351-32, 32351-34, 32351-36, 32351-38, 32351-40, 32351-42, 32351-44, 32351-46, 32351-48, 32351-50, 32351-55, 32351-60, 32351-65, 32351-70, 32351-75, 32351-80, 32351-85, 32352-16, 32352-18, 32352-20, 32352-22, 32352-24, 32352-26, 32352-28, 32352-30, 32352-32, 32352-34, 32352-36, 32352-38, 32352-40, 32352-42, 32352-44, 32352-46, 32352-48, 32352-50, 32352-55, 32352-60, 32352-65, 32352-70, 32352-75, 32352-80, 32352-85, 32352-90, 32352-95, 32352-100, 32352-105, 32352-110, 32352-115, 32352-120, 32455-18, 32455-20, 32455-22, 32455-24, 32455-26, 32455-28, 32455-30, 32455-32, 32455-34, 32455-36, 32455-38, 32455-40, 32455-42, 32455-44, 32455-46, 32455-48, 32455-50, 32455-52, 32455-54, 32455-56, 32455-58, 32455-60, 32455-65, 32455-70, 32455-75, 32455-80, 32455-85, 32455-90, 32475-32.
8Cortical Screw, Locking; Article Numbers: 37455-18, 37455-20, 37455-22, 37455-24, 37455-26, 37455-28, 37455-30, 37455-32, 37455-34, 37455-36, 37455-38, 37455-40, 37455-42, 37455-44, 37455-46, 37455-48, 37455-50, 37455-52, 37455-54, 37455-56, 37455-60, 37455-65, 37455-70, 37455-75, 37455-80, 37455-85, 37455-90.
9Curved Plate; Article Numbers: 211911-4, 211911-5, 211911-6, 211911-7, 211911-8, 211911-10, 211911-12, 211911-14, 211911-16, 211911-20.
10Posterior Column Plate, Left; Article Numbers: 212121-6.
11Posterior Column Plate, Right; Article Numbers: 212131-6.
12Posterior Wall Plate, Extended, Left; Article Numbers: 212101-SM.
13Posterior Wall Plate, Extended, Left; Article Numbers: 212101-LA.
14Posterior Wall Plate, Extended, Right; Article Numbers: 212111-LA, 212111-SM.
15Posterior Wall Plate, Left; Article Numbers: 212141-7, 212141-8.
16Posterior Wall Plate, Right; Article Numbers: 212151-7, 212151-8.
17PRS Plate; Article Numbers: 21194-6, 21194-7, 21194-8, 21195-10, 21195-12, 21195-7.
18Quadrilateral Buttress Plate; Article Numbers: 21208-13, 21209-13.
19Quadrilateral Buttress Plate; Article Numbers: 21208-11, 21209-11.
20Rim Plate, Left; Article
Lot codes and dates
  • 1
  • Article Number (Lot Numbers)
    • 21218-16 (679/112166
    • 679/122229
    • 679/122230
    • 679/122304)
    • 21219-16 (679/012441
    • 679/062456
    • 679/0624561
    • 679/112167
    • 679/122228). 2
  • Article Number (Lot Numbers)
    • 21218-14(679/032417
    • 679/102231
    • 679/112158
    • 679/112164
    • 679/122231)
    • 21219-14 (679/012505
    • 679/112159
    • 679/112165
    • 679/122227
    • 679/122305). 3
  • Article Number (Lot Numbers)
    • 21216-10 (679/032501
    • 679/062453
    • 679/072276
    • 679/072510
    • 679/092203
    • 679/092401
    • 679/112168
    • 679/112409
    • 679/122270)
    • 21216-12 (679/032503
    • 679/062344
    • 679/062454
    • 679/072277
    • 679/092204
    • 679/112170
    • 679/112413
    • 679/122271)
    • 21217-10 (679/032502
    • 679/062346
    • 679/072278
    • 679/092402
    • 679/092404
    • 679/102216
    • 679/112169
    • 679/112423)
    • 21217-12 (679/022238
    • 679/062345
    • 679/072513
    • 679/092403
    • 679/112171
    • 679/122407
    • 679/122426). 4
  • Article Number (Lot Numbers)
    • 30591-36 (18/922090)
    • 30591-70 (18/231539
    • 18/775273)
    • 30591-75 (18/751307)
    • 30591-80 (18/777295)
    • 30591-85 (18/301308)
    • 30591-90 (18/311309). 5
  • Article Number (Lot Numbers)

    244 of 244 codes

    • 37422-12-N (18/145897
    • 18/461842)
    • 37422-14-N (18/215281
    • 679/032001
    • 679/062320
    • 679/092355
    • 679/122326)
    • 37422-16-N (679/052229
    • 679/052307
    • 679/102214
    • 679/102306
    • 679/122329)
    • 37422-18-N (18/240520
    • 18/452529
    • 18/473354
    • 679/052316
    • 679/102215
    • 679/102337
    • 679/122330)
    • 37422-20-N (679/0323147
    • 679/072306
    • 679/102211
    • 679/102338
    • 679/122331)
    • 37422-22-N (18/092876
    • 18/543636
    • 679/012406
    • 679/062361
    • 679/072312
    • 679/102212
    • 679/102348)
    • 37422-24-N (679/012407
    • 679/052333
    • 679/072313
    • 679/102349)
    • 37422-26-N (679/012435
    • 679/062316
    • 679/072322
    • 679/102353)
    • 37422-28-N (18/192499
    • 679/012422
    • 679/032211
    • 679/062317
    • 679/062323
    • 679/072323
    • 679/102361)
    • 37422-30-N (18/217289
    • 679/012436
    • 679/032212
    • 679/0323142
    • 679/072324
    • 679/102354)
    • 37422-32-N (18/218290
    • 679/012437
    • 679/052335
    • 679/052337
    • 679/072329
    • 679/112306)
    • 37422-34-N (18/031830
    • 18/219291
  • Article Number (Lot Numbers)

    144 of 144 codes

    • 31851-60 (18/373463
    • 18/813133)
    • 31851-65 (18/374464)
    • 31851-70 (18/375465)
    • 31851-75 (18/376467)
    • 31851-80 (18/125212
    • 18/377468
    • 18/431563
    • 18/867967)
    • 31851-85 (18/044945
    • 18/378469
    • 18/441564)
    • 31851-90 (18/045946
    • 18/343266
    • 18/451565)
    • 31851-95 (18/046947
    • 18/128224
    • 18/379470
    • 18/461566)
    • 31851-100 (18/129225
    • 18/471567
    • 18/821469
    • 18/860968)
    • 31851-105 (18/380471)
    • 31851-110 (18/901298
    • 18/387472)
    • 31851-115 (18/381473
    • 18/048949)
    • 31851-120 (18/049950
    • 18/133227
    • 18/511577
    • 18/862970)
    • 31851-125 (18/050951
    • 18/347474
    • 18/521578)
    • 31851-130 (18/051952
    • 18/344368
    • 18/531579)
    • 31851-135 (18/382475
    • 18/541580)
    • 31851-140 (18/052953
    • 18/551777
    • 18/863971)
    • 31851-145 (18/054954
    • 18/137229
    • 18/345351
    • 18/561779)
    • 31851-150 (18/138260
    • 18/191042
    • 18/346352
    • 18/571780
    • 18/797898)
    • 31851-155 (18/201043
    • 18/384476)
    • 31851-160 (18/062955
    • 18/799900
    • 18/866972)
    • 31851-165 (18/063956
    • 18/211045
    • 18/385477)
  • Article Number (Lot Numbers)

    439 of 439 codes

    • 32351-10 (18/019937
    • 18/208200
    • 18/731287
    • 679/052205
    • 679/122249)
    • 32351-12 (18/020938
    • 18/209211
    • 18/741316
    • 679/062203
    • 679/102243)
    • 32351-14 (18/210212
    • 18/501230
    • 18/761312
    • 679/012324
    • 679/032524
    • 679/042419
    • 679/062225
    • 679/082501
    • 679/122207)
    • 32351-16 (18/022940
    • 18/211212
    • 18/771313
    • 679/022311
    • 679/022533
    • 679/032525
    • 679/042421
    • 679/072201
    • 679/092501
    • 679/122204)
    • 32351-18 (18/212213
    • 18/781322
    • 18/801041
    • 679/022312
    • 679/032526
    • 679/042427
    • 679/072202
    • 679/102501
    • 679/122208)
    • 32351-20 (18/024942
    • 18/181975
    • 18/213214
    • 18/791323
    • 679/032527
    • 679/042428
    • 679/102502
    • 679/112225)
    • 32351-22 (18/025943
    • 18/214215
    • 18/801324
    • 18/8013241
    • 18/821061
    • 679/052219
    • 679/112235)
    • 32351-24 (18/026988
    • 18/215216
    • 18/811325
    • 18/8113251
    • 18/831062
    • 679/052206
    • 679/102239)
  • Article Number (Lot Numbers)
    • 37455-18 (18/231558)
    • 37455-20 (18/021319)
    • 37455-22 (18/211320)
    • 37455-24 (18/671425
    • 18/231558)
    • 37455-26 (18/221322
    • 18/231449)
    • 37455-28 (18/041323)
    • 37455-30 (18/231324)
    • 37455-32 (18/051325)
    • 37455-34 (18/241326)
    • 37455-36 (18/061375
    • 26/F62605)
    • 37455-38 (18/251376)
    • 37455-40 (18/532513
    • 18/691442
    • 26/F62606)
    • 37455-42 (18/151343
    • 18/261380)
    • 37455-44 (18/081388)
    • 37455-46 (18/231515)
    • 37455-48 (18/231514)
    • 37455-50 (18/281394)
    • 37455-52 (18/101395)
    • 37455-54 (18/701444)
    • 37455-56 (18/111408
    • 18/656368)
    • 37455-60 (18/121449
    • 18/572515)
    • 37455-65 (18/131479)
    • 37455-70 (18/141480
    • 26/F62607)
    • 37455-75 (18/151481
    • 26/F62608)
    • 37455-80 (18/686476
    • 26/F62609)
    • 37455-85 (18/171483
    • 26/F62610)
    • 37455-90 (18/181484). 9
  • Article Number (Lot Numbers)

    64 of 64 codes

    • 211911-4 (00/0825-10
    • 679/012425
    • 679/022531
    • 679/0323131
    • 679/062430
    • 679/0624301
    • 679/102431
    • 679/122267)
    • 211911-5 (00/0724-28
    • 00/1225-04
    • 679/012426
    • 679/022321
    • 679/022518
    • 679/0323132
    • 679/052527
    • 679/0624311
    • 679/0624312
    • 679/102432)
    • 211911-6 (00/1024-15
    • 679/012427
    • 679/022322
    • 679/022501
    • 679/042513
    • 679/062432
    • 679/0624322
    • 679/102433
    • 679/112177)
    • 211911-7 (00/0724-31
    • 00/0724-32
    • 00/0724-33
    • 00/0724-34
    • 00/0724-35
    • 00/0725-16
    • 00/1225-05
    • 679/022323
    • 679/022502
    • 679/052529
    • 679/062231
    • 679/102434)
    • 211911-8 (679/012428
    • 679/022503
    • 679/022532
    • 679/0323135
    • 679/112178
    • 679/112407)
    • 211911-10 (00/0724-39
    • 00/1024-17
    • 679/0323127
    • 679/102429
    • 679/112179
    • 679/122266)
    • 211911-12 (679/0323128
    • 679/102228
    • 679/112203
    • 679/112219)
    • 211911-14 (679/0323129
    • 679/102229
    • 679/112221)
    • 211911-16 (679/0323130
    • 679/062232
  • Article Number (Lot Numbers)
    • 212121-6 (679/052152
    • 679/062338
    • 679/122235). 11
  • Article Number (Lot Numbers)
    • 212131-6 (679/062319
    • 679/122234). 12
  • Article Number (Lot Numbers)
    • 212101-SM (679/042515
    • 679/052322
    • 679/122215
    • 679/122303
    • 679/122402). 13
  • Article Number (Lot Numbers)
    • 212101-LA (00/0724-48
    • 00/1024-09
    • 679/062313
    • 679/062443
    • 679/112206
    • 679/122302
    • 679/122405). 14
  • Article Number (Lot Numbers)
    • 212111-LA (679/032421
    • 679/042516
    • 679/062347
    • 679/062402
    • 679/062445
    • 679/122414)
    • 212111-SM (00/0724-65
    • 00/1024-10
    • 00/1024-11
    • 679/022530
    • 679/032246
    • 679/062318
    • 679/062403
    • 679/062473
    • 679/092237
    • 679/112015
    • 679/122406). 15
  • Article Number (Lot Numbers)
    • 212141-7 (00/0724-81
    • 00/0724-85
    • 679/032331
    • 679/052168
    • 679/062448
    • 679/122214)
    • 212141-8 (679/022408
    • 679/032332
    • 679/052429
    • 679/062449
    • 679/0624491
    • 679/062474
    • 679/122233). 16
  • Article Number (Lot Numbers)
    • 212151-7 (00/0624-06
    • 679/012449
    • 679/052153
    • 679/062219
    • 679/062450
    • 679/062475
    • 679/102230
    • 679/112239)
    • 212151-8 (00/0624-11
    • 00/0724-51
    • 679/012450
    • 679/032248
    • 679/062451
    • 679/072508). 17
  • Article Number (Lot Numbers)
    • 21194-6 (679/042247)
    • 21194-7 (679/042249)
    • 21194-8 (679/042250)
    • 21195-10 (679/042252)
    • 21195-12 (679/042253)
    • 21195-7 (679/032221). 18
  • Article Number (Lot Numbers)
    • 21208-13 (679/032414
    • 679/052428
    • 679/062122
    • 679/102435
    • 679/112162
    • 679/112174
    • 679/122221
    • 679/122222)
    • 21209-13 (679/062442
    • 679/0624421
    • 679/112163
    • 679/112175
    • 679/112408
    • 679/122236). 19
  • Article Number (Lot Numbers)
    • 21208-11 (679/012429
    • 679/062440
    • 679/0624401
    • 679/112160
    • 679/112172
    • 679/122219)
    • 21209-11 (679/062441
    • 679/112161
    • 679/112173
    • 679/112412
    • 679/122237
    • 679/122238
    • 679/122239). 20
  • Article Number (Lot Numbers)
    • 212061-10 (00/0724-110
    • 679/062311
    • 679/112217
    • 679/122218)
    • 212061-14 (00/0724-42
    • 00/0724-47
    • 679/032238
    • 679/032337
    • 679/062312). 21
  • Article Number (Lot Numbers)
    • 212071-10 (679/032415
    • 679/052329)
    • 212071-14 (679/032338
    • 679/032416). 22
  • Article Number (Lot Numbers)
    • 211751-5 (679/052320
    • 679/112180
    • 679/112202
    • 679/112220)
    • 211771-4 (679/052321
    • 679/102227
    • 679/122301). 23
  • Article Number (Lot Numbers)
    • 211821-10 (679/012423
    • 679/032333
    • 679/062426
    • 679/112176)
    • 211821-11 (00/0724-71
    • 00/0724-74
    • 679/032334)
    • 211821-12 (679/022320)
    • 211821-14 (679/012424
    • 679/122217). 24
  • Article Number (Lot Numbers)
    • 21161-4 (679/092320
    • 679/112201)
    • 21161-6 (679/032305
    • 679/032306
    • 679/042304
    • 679/052506
    • 679/062218)
    • 211621-4 (00/0724-18
    • 00/0724-63
    • 679/042305
    • 679/062423
    • 679/102226
    • 679/112414)
    • 211621-6 (00/0825-13
    • 679/022529
    • 679/042306
    • 679/062424
    • 679/112415). 25
  • Article Number (Lot Numbers)
    • 211631-6 (00/0125-35
    • 679/022515
    • 679/032315
    • 679/062302
    • 679/062425
    • 679/0624251
    • 679/112411)
    • 211631-8 (00/0724-118
    • 00/1220-11
    • 679/062303
    • 679/122216)
Amount recalled
46,637 units

This recall covers 17 products

The agency filed one notice per product. You are reading one of them; the other 16 are below.

4 more are in the archive.

Where it was sold

Why it was recalled

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

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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By hazard

Other recalls from I.T.S. GmbH

Where it was distributed

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.