Skip to content
Lower risk Medical device recall · FDA · Published January 22, 2024

LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head: Mislabeled Packaging May

Waldemar Link recalls specific E-Poly Liner models due to mislabeled packaging that could delay surgery for patients with hip issues. Affected units have item numbers 184-280/12 and lot numbers 2334253, 2325426.

🇺🇸 FDA recall #Z-1219-2024Medical deviceWaldem:Link ›
Take action

Contact the company

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

Waldemar Link is recalling certain E-Poly Liner implants for patients with hip problems because the packaging incorrectly labels the product type. This mislabeling might cause delays in surgery if the wrong type is used during procedures. Read more at govinfonow.com/recall/56277-link-bimobile-dual-mobility-system-e-poly-liner-for-28mm.

Source Summary by GovInfoNow · govinfonow.com/recall/56277-link-bimobile-dual-mobility-system-e-poly-liner-for-28mm · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1219-2024

Cite this page

“LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head: Mislabeled Packaging May.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/56277-link-bimobile-dual-mobility-system-e-poly-liner-for-28mm. Based on FDA recall #Z-1219-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1219-2024%22&limit=1).

The FDA announced on Jan. 22, 2024, that Waldemar Link GmbH & Co. KG is recalling LINK BiMobile Dual Mobility System E-Poly Liner for mislabeling that may delay surgery. The device is indicated for patients with mobility-limiting diseases or hip fractures.

How to tell if you have it

  • Brand: Waldem:Link
  • Product: LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell
  • Item Number: 184-280/12
  • UDI-DI: 04026575230747
  • Lot Numbers: 2334253, 2325426

The hazard

The packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G. This mislabeling may cause a delay in surgery.

Context

GovInfoNow's records show Waldemar Link GmbH & Co. KG has 21 other recalls on record since Dec. 4, 2018. Other recent recalls of similar products include the Endo-Model Tibial Plateau Recall (July 6, 2026), the Embrace Drill Tower Wedged Recall (Feb. 11, 2026), and the Endo-Model Plateau Recall (Jan. 12, 2026).

How to tell if you have this one

Check for item number 184-280/12 and lot numbers 2334253 or 2325426 on the packaging. The product is intended for patients with hip joint issues, fractures, or mobility-limiting conditions.

  • Brand
    Waldem:Link
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Verify Product Details

    Check the item number (184-280/12) and lot numbers (2334253, 2325426) on the packaging to confirm if the product is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 4 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA distribution: “Worldwide - US Nationwide distribution in the states of IL, IN, FL, WA and the countries of Germany, Switzerland.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Illinois, Indiana, Washington.

Recall timeline

FDA published this recall 44 days after the firm started it.

1. Firm started the recall: Jan 22, 202412. FDA classified it Class II: Feb 29, 202423. Published in FDA’s Enforcement Report: Mar 6, 202432024
  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.

✎ GovInfoNow

Questions people ask

Is there a risk of serious injury from this product?

The recall is for mislabeling that may delay surgery, not a direct risk of injury. The hazard level is low risk.

Similar recalls

Latest medical device recalls

Keep exploring

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-1219-2024 (January 22, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1219-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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