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Unrated Medical device recall · FDA · Published January 12, 2026

Waldemar Link Endo-Model Plateau Recall: Risk of Screw Detachment

Waldemar Link recalls Endo-Model Replacement Plateau (item 15-002:11) due to potential screw detachment from fracture. Affected units have specific serial numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1521-2026Medical deviceWaldemar Link ›
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Contact the company

Recalling firmWaldemar Link GmbH & Co. KG (Mfg Site)Ost Str. 4-10 · Norderstedt, Germany
✎ GovInfoNow plain-language explainer

Waldemar Link is recalling Endo-Model Replacement Plateau items with serial numbers 2549126 and 2549127 because a plateau screw could detach if the bushing fractures. This could lead to implant failure or injury if not addressed. Read more at govinfonow.com/recall/50162-waldemar-link-endo-model-plateau-recall-risk-of-screw-detachment.

Source Summary by GovInfoNow · govinfonow.com/recall/50162-waldemar-link-endo-model-plateau-recall-risk-of-screw-detachment · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1521-2026

Cite this page

“Waldemar Link Endo-Model Plateau Recall: Risk of Screw Detachment.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50162-waldemar-link-endo-model-plateau-recall-risk-of-screw-detachment. Based on FDA recall #Z-1521-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1521-2026%22&limit=1).

Waldemar Link GmbH & Co. KG recalled Endo-Model Replacement Plateau devices on Jan. 12, 2026, due to potential bushing detachment from the screw shaft, according to the FDA. The recall affects items with item number 15-0027/11.

How to tell if you have it

  • Brand: Waldemar Link
  • Product: Endo-Model Replacement Plateau
  • Item Number: 15-0027/11
  • UDI-DI: 04026575431953
  • Lot Numbers: 2549126, 2549127

The hazard

The device poses a hazard because the bushing could detach from the screw shaft due to a longitudinal fracture in the plateau screw. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Waldemar Link has issued 21 other recalls since Dec. 4, 2018. Recent brand recalls include an Endo-Model Tibial Plateau issue reported on July 6, 2026, and an Embrace Drill Tower error noted on Feb. 11, 2026. Other recent recalls of similar products include the Genesis Screw-In Anchor (Dec. 17, 2025), the Wilson-Cook Instinct Plus Endoscopic Clipping Device (March 3, 2026), and the Olympus HX-400U-30 Ligating Device (Oct. 30, 2025).

How to tell if you have this one

Check for serial numbers 2549126 or 2549127 on the Endo-Model Replacement Plateau. The product was sold with item number 15-0027/11.

  • Brand
    Waldemar Link
  • Category
    Medical device
FDA recall event · 13 products

All 13 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
Recall numberProduct, codes & lotsQuantity
Z-1511-2026Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;; Item Number: 16-2840/05; UDI-DI: 04026575359240; Serial/Lot Number: 250513/2083, 250513/2085 , 250513/2086, 250513/2089, 250513/2090, 250513/2092, 250513/2093, 250513/2097 , 250513/2100, 250513/2102, 250513/2104, 250513/2107, 250513/2108, 251013/3245 , 251013/3247, 251013/3250, 251013/3251, 251013/3252, 251013/3253, 251105/0013 , 251105/0016, 251105/0018, 251105/0020, 251105/0032, 251105/0034, 251105/0036 , 251105/0037, 251105/0038, 251105/0039, 250513/2106, 250513/2099, 251105/0014 , 251105/0040, 251105/0002, 250513/2087, 250513/2091, 251013/3246, 251105/0019 , 251013/3249, 251105/0011, 251105/0012, 250513/2103, 250513/2105, 251013/3254;44 units (1 US, 43 OUS)
Z-1512-2026Endo-Model Replacement Plateau; Item Number: 15-0027/15;; Item Number: 15-0027/15; UDI-DI: 04026575432127; Serial/Lot Number: 2549190;3 units
Z-1513-2026Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;; Item Number: 16-2840/02; UDI-DI: 04026575359233; Serial/Lot Number: 250925/0640 , 250925/0641, 250925/0642, 250925/0646, 250925/0650, 250925/0652, 250925/0653 , 250925/0656, 250925/0658, 250925/0669, 250925/0670, 250925/0680, 250925/0681 , 250925/0682, 250925/0687, 250925/0689, 250925/0690, 250925/0691, 250925/0693 , 250925/0694, 251110/3293, 250925/0660, 250925/0661, 250925/0684, 250925/0685 , 250925/0657, 250925/0663, 250925/0659, 250925/0678, 251110/3288, 251110/3292 , 251110/3303, 251110/3313, 250925/0683, 250925/0674, 250925/0644, 250925/0665 , 250925/0668, 250925/0671, 250925/0673, 250925/0676, 250925/0664 , 250925/0651 , 251110/3297, 251110/3289, 250925/0639, 250925/0648, 250925/0688, 250925/0696;49 units (OUS only)
Z-1514-2026Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;; Item Number: 16-2840/07; UDI-DI: 04026575359257; Serial/Lot Number: 250925/0480 , 250925/0481, 250925/0482, 250925/0483, 250925/0484, 250925/0486, 250925/0489 , 250925/0491, 250925/0492, 250925/0494, 250925/0503, 250925/0504, 250925/0345 , 250925/0346, 250925/0349, 250925/0350, 250925/0351, 250925/0352, 250925/0356 , 250925/0369, 250925/0501, 250925/0365, 250925/0368, 250925/0490, 250925/0488 , 250925/0479, 250925/0495, 250925/0500, 250925/0496, 250925/0499, 250925/0367;31 units (OUS only)
Z-1515-2026Endo-Model Replacement Plateau; Item Number: 15-2835/12;; Item Number: 15-2835/12; UDI-DI: 04026575316564; Serial/Lot Number: 241210/1809;1 unit (OUS only)
Z-1516-2026Endo-Model Replacement Plateau; Item Number: 15-2836/11;; Item Number: 15-2836/11; UDI-DI: 04026575316571; Serial/Lot Number: 250623/3643, 250623/3644, 250623/3645, 250623/3646, 250623/3648, 250812/2812, 250812/2811;7 units (OUS only)
Z-1517-2026Endo-Model Replacement Plateau; Item Number: 15-8030/12;; Item Number: 15-8030/12; UDI-DI: 04026575048151; Serial/Lot Number: 250721/0194, 250721/0212, 250721/0211, 250721/0209;4 units (all OUS)
Z-1518-2026Endo-Model Replacement Plateau; Item Number: 15-8521/09;; Item Number: 15-8521/09; UDI-DI: 04026575383238; Serial/Lot Number: 250728/0038, 250728/0039, 250728/0040, 250728/0041, 250728/0042, 250728/0043, 250728/0044, 250728/0045;8 units (OUS only)
Z-1519-2026Endo-Model Replacement Plateau; Item Number: 15-8521/11;; Item Number: 15-8521/11; UDI-DI: 04026575383245; Serial/Lot Number: 250728/2220, 250728/2222, 250728/2223, 250728/2224, 250728/2225, 250728/2226, 250728/2227;7 units (OUS only)
Z-1520-2026Endo-Model Replacement Plateau; Item Number: 15-8521/15;; Item Number: 15-8521/15; UDI-DI: 04026575383283; Serial/Lot Number: 250805/0020, 250805/0021, 250805/0023, 250805/0024;4 units (OUS only)
Z-1521-2026Endo-Model Replacement Plateau; Item Number: 15-0027/11;; Item Number: 15-0027/11; UDI-DI: 04026575431953; Serial/Lot Number: 2549126, 2549127;2 units (OUS only)
Z-1522-2026Endo-Model Replacement Plateau; Item Number: 15-0027/12;; Item Number: 15-0027/12; UDI-DI: 04026575431960; Serial/Lot Number: 2549036;1 unit (OUS only)
Z-1523-2026Endo-Model Replacement Plateau; Item Number: 15-0027/16;; Item Number: 15-0027/16; UDI-DI: 04026575432134; Serial/Lot Number: 2550412, 2550413, 2549228;3 units (OUS only)
Based on the official FDA remedy

What to do — step by step

  1. Check Product Serial Number

    Look for serial numbers 2549126 or 2549127 on the Endo-Model Replacement Plateau.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Jan 12, 202612. FDA classified it Class II: Mar 10, 202623. Published in FDA’s Enforcement Report: Mar 18, 202632026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1521-2026 (January 12, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1521-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA