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FDA recall, , Moderate risk

Waldemar Link Endo-Model Replacement Plateaus and Connection Components

Endo-Model Replacement Plateau and SL Connection Components may have a bushing that detaches from the screw shaft.

Summary by Recall Canary from the FDA notice

What happened

Waldemar Link GmbH & Co. KG (Mfg Site), based in Norderstedt, Germany, recalled Endo-Model Replacement Plateau and Endo-Model SL Connection Component incl. PE-Plateau products because of the potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

The recall began January 12, 2026, and was added to the FDA's Enforcement Report on March 10, 2026. Distribution included worldwide, with US nationwide distribution in New Jersey and other countries listed.

More device defect recalls

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

Match your product and all the details in one listed combination.

A UDI-DI is the device identifier printed with the barcode on the device label.

  1. Endo-Model Replacement Plateau

    1. UDI-DI
      • 04026575048151
      Item code
      • 15-8030/12
      Lot code
      • 250721
      • 0194
      • 0212
      • 0211
      • 0209
    2. UDI-DI
      • 04026575431953
      Item code
      • 15-0027/11
      Lot code
      • 2549126
      • 2549127
    3. UDI-DI
      • 04026575383283
      Item code
      • 15-8521/15
      Lot code
      • 250805
      • 0020
      • 0021
      • 0023
      • 0024
    4. UDI-DI
      • 04026575432127
      Item code
      • 15-0027/15
      Lot code
      • 2549190
    5. UDI-DI
      • 04026575316564
      Item code
      • 15-2835/12
      Lot code
      • 241210
      • 1809
    6. UDI-DI
      • 04026575316571
      Item code
      • 15-2836/11
      Lot code
      • 250623
      • 3643
      • 3644
      • 3645
      • 3646
      • 3648
      • 250812
      • 2812
      • 2811
    7. UDI-DI
      • 04026575383238
      Item code
      • 15-8521/09
      Lot code
      • 250728
      • 0038
      • 0039
      • 0040
      • 0041
      • 0042
      • 0043
      • 0044
      • 0045
    8. UDI-DI
      • 04026575383245
      Item code
      • 15-8521/11
      Lot code
      • 250728
      • 2220
      • 2222
      • 2223
      • 2224
      • 2225
      • 2226
      • 2227
    9. UDI-DI
      • 04026575432134
      Item code
      • 15-0027/16
      Lot code
      • 2550412
      • 2550413
      • 2549228
    10. UDI-DI
      • 04026575431960
      Item code
      • 15-0027/12
      Lot code
      • 2549036

  2. Endo-Model SL Connection Component incl. PE-Plateau

    1. UDI-DI
      • 04026575359240
      Item code
      • 16-2840/05
      Lot code
      • 250513
      • 2100
      • 2102
      • 2104
      • 2107
      • 2108
      • 251013
      • 3245
      • 3247
      • 3250
      • 3251
      • 3252
      • 3253
      • 251105
      • 0013
      • 0016
      • 0018
      • 0020
      • 0032
      • 0034
      • 0036
      • 0037
      • 0038
      • 0039
      • 2106
      • 0014
      • 0040
      • 0002
      • 3246
      • 0019
      • 3249
      • 0011
      • 0012
      • 2103
      • 2105
      • 3254
    2. UDI-DI
      • 04026575359257
      Item code
      • 16-2840/07
      Lot code
      • 250925
      • 0480
      • 0481
      • 0482
      • 0483
      • 0484
      • 0486
      • 0489
      • 0491
      • 0492
      • 0494
      • 0503
      • 0504
      • 0345
      • 0346
      • 0349
      • 0350
      • 0351
      • 0352
      • 0356
      • 0369
      • 0501
      • 0365
      • 0368
      • 0490
      • 0488
      • 0479
      • 0495
      • 0500
      • 0496
      • 0499
      • 0367
    3. UDI-DI
      • 04026575359233
      Item code
      • 16-2840/02
      Lot code
      • 250925
      • 0640
      • 0641
      • 0642
      • 0646
      • 0650
      • 0652
      • 0653
      • 0656
      • 0658
      • 0669
      • 0670
      • 0680
      • 0681
      • 0682
      • 0687
      • 0689
      • 0690
      • 0691
      • 0693
      • 0694
      • 251110
      • 3293
      • 0660
      • 0661
      • 0684
      • 0685
      • 0657
      • 0663
      • 0659
      • 0678
      • 3288
      • 3292
      • 3303
      • 3313
      • 0683
      • 0674
      • 0644
      • 0665
      • 0668
      • 0671
      • 0673
      • 0676
      • 0664
      • 0651
      • 3297
      • 3289
      • 0639
      • 0648
      • 0688
      • 0696

Recall details

Company began the recall
Sold in

Worldwide - US Nationwide distribution in the state of New Jersey and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.

Company
Waldemar Link GmbH & Co. KG (Mfg Site)Norderstedt, Germany
Hazard
Device defect
Risk

Moderate risk

Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.

FDA Class II recall · How risk is rated

Event ID
98342
Recall numbers
Z-1511-2026 to Z-1523-2026

All recalls from Waldemar Link GmbH & Co. KG (Mfg Site)

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. In FDA's weekly enforcement report

  4. Listed on Recall Canary

  5. Summary updated

Same product, other recalls

Summary by Recall Canary, written with AI · summary updated Oct 3, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)