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Lower risk Medical device recall · FDA · Published July 14, 2023

Waldemar Link MobileLink Acetabular Cup System: Incorrect Offset Labeling

Waldemar Link recalls MobileLink Acetabular Cup System with incorrect offset labeling. This may affect surgical implants for hip replacements. Affected units have specific UDI-DI and lot numbers.

🇺🇸 FDA recall #Z-2641-2023Medical deviceWaldemar Link ›
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Contact the company

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

Waldemar Link is recalling a hip replacement component due to incorrect offset labeling on the product. This could lead to improper surgical fit if used without correction. Read more at govinfonow.com/recall/57647-waldemar-link-mobilelink-acetabular-cup-system-incorrect-offset-labeling.

Source Summary by GovInfoNow · govinfonow.com/recall/57647-waldemar-link-mobilelink-acetabular-cup-system-incorrect-offset-labeling · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2641-2023

Cite this page

“Waldemar Link MobileLink Acetabular Cup System: Incorrect Offset Labeling.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57647-waldemar-link-mobilelink-acetabular-cup-system-incorrect-offset-labeling. Based on FDA recall #Z-2641-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2641-2023%22&limit=1).

The FDA announced on July 14, 2023, that Waldemar Link GmbH & Co. KG is recalling MobileLink Acetabular Cup System components due to incorrect labeling of the offset. The agency issued recall number Z-2641-2023 for the voluntary Class II action.

How to tell if you have it

  • Brand: Waldemar Link
  • Product: MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees
  • UDI-DI: 04026575182329
  • Item Number: 183-610/05
  • Lots: 210526/0781; 210526/0777; 210526/0779; 210526/0771; 210526/0772; 210526/0783; 210526/0784; 210526/0778
  • Distribution: AL, NJ, NV

The hazard

The product is labeled with an incorrect offset. The FDA classifies this as a Class II recall.

Context

GovInfoNow's records show Waldemar Link GmbH & Co. KG has 21 other recalls on record since December 4, 2018. Other recent recalls of similar products include Encore Medical EMPOWR Acetabular System Recall (January 5, 2026) and U2 Total Knee System: Incorrect Implant Orientation Risk (March 19, 2026).

How to tell if you have this one

Check for the UDI-DI number 04026575182329 and lot numbers 210526/0771 through 210526/0784 on the product packaging or label.

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

What to do — step by step

  1. Check Product Label

    Look for the UDI-DI number 04026575182329 and lot numbers 210526/0771 through 210526/0784 on the product packaging or label.

Where it went and when

Where it was distributed

Distributed in 3 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: yesNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: yesNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: yesALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “Domestic distribution to AL, NJ, NV.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Nevada, New Jersey.

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: Jul 14, 202312. FDA classified it Class II: Sep 26, 202323. Published in FDA’s Enforcement Report: Oct 4, 202332023
  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

What is the specific model of the recalled product?

The recalled product is the MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees.

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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-2641-2023 (July 14, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2641-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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