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Use caution Medical device recall · FDA · Published July 3, 2023

Waldemar Link LINK MP Monoblock Hip Stem Recall: Increased Removal Force Risk

Waldemar Link recalls LINK MP Monoblock Hip Stem (Size 17) for potential increased force needed during removal, possibly prolonging surgery. Affected patients with mobility issues may need surgical adjustments.

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

🇺🇸 FDA recall #Z-2348-2023Medical 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 hip stem trial instruments (Size 17) that may require more force to remove after impaction. This could lead to longer surgery or necessary procedure changes for patients with mobility-limiting conditions. Read more at govinfonow.com/recall/57746-waldemar-link-link-mp-monoblock-hip-stem-recall-increased-removal.

Source Summary by GovInfoNow · govinfonow.com/recall/57746-waldemar-link-link-mp-monoblock-hip-stem-recall-increased-removal · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2348-2023

Cite this page

“Waldemar Link LINK MP Monoblock Hip Stem Recall: Increased Removal Force Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57746-waldemar-link-link-mp-monoblock-hip-stem-recall-increased-removal. Based on FDA recall #Z-2348-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2348-2023%22&limit=1).

The FDA announced on July 3, 2023, that Waldemar Link GmbH & Co. KG is recalling LINK MP Monoblock Hip Stem Trial Stem Instruments, Size 17. The agency cited a potential for prolonged surgery or modified procedures due to increased removal force.

How to tell if you have it

  • Brand: Waldemar Link
  • Product: LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17
  • Item Number: 136-117/00
  • UDI-DI: 04026575182114
  • Lot Numbers: B922124, B932051, C005064, C211011
  • Units affected: 24

The hazard

The recall addresses the potential for increased force to be required to remove the LINK MP Monoblock trial hip stems after impaction. This issue may lead to prolongation of surgery or require modification of the surgical procedure.

Context

GovInfoNow's records show Waldemar Link GmbH & Co. KG has issued 21 other recalls since December 4, 2018. Recent brand recalls include an Endo-Model Tibial Plateau recall on July 6, 2026, and an Embrace Drill Tower Wedged (25mm) recall on February 11, 2026. Other recent recalls of similar products include a Merit Medical Allwell Angioplasty Pack recall (December 4, 2025), a Merit Medical Custom Procedure Kit recall (December 4, 2025), and a Merit Medical Vascular Tray recall (December 4, 2025).

How to tell if you have this one

Check for the item number 136-117/00 and UDI-DI 04026575182114 on the instrument. Lot numbers B922124, B932051, C005064, and C211011 are also associated with this recall.

  • Brand
    Waldemar Link
  • Category
    Medical device
FDA recall event · 12 products

All 12 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
    US Nationwide distribution.
Recall numberProduct, codes & lotsQuantity
Z-2345-2023LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-114/00; UDI-DI: 04026575182084 Lot Numbers: B923005 B93204814 units
Z-2346-2023LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-115/00; UDI-DI: 04026575182091 Lot Numbers: B923004 B932049 C005089 C21100924 units
Z-2347-2023LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-116/00; UDI-DI: 04026575182107 Lot Numbers: B923003 B932050 C005075 C21101024 units
Z-2348-2023LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-117/00; UDI-DI: 04026575182114 Lot Numbers: B922124 B932051 C005064 C21101124 units
Z-2349-2023LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-118/00; UDI-DI: 04026575182121 Lot Numbers: B922123 B932052 C005067 C21101224 units
Z-2350-2023LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-119/00; UDI-DI: 04026575182138 Lot Numbers: B922122 B932054 C005071 C21101324 units
Z-2351-2023LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-120/00; UDI-DI: 04026575182145 Lot Numbers: B922121 B933166 C005012 C21101424 units
Z-2352-2023LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-121/00; UDI-DI: 04026575182152 Lot Numbers: B922120 B933167 C005021 C21101524 units
Z-2353-2023LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-22/00; UDI-DI: 04026575182169 Lot Numbers: B922119 B933168 C005032 C21101624 units
Z-2354-2023LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-23/00; UDI-DI: 04026575182176 Lot Numbers: B922118 B933169 C005023 C211017 C24004824 units
Z-2355-2023LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-24/00; UDI-DI: 04026575182183 Lot Numbers: B922115 B933170 C005042 C211018 C24004924 units
Z-2356-2023LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-25/00; UDI-DI: 04026575182190 Lot Numbers: B922113 B934176 C005048 C211019 C24005024 units
Based on the official FDA remedy

What to do — step by step

  1. Check Instrument Details

    Verify the item number (136-117/00) and UDI-DI (04026575182114) on the hip stem instrument.

Where it went and when

Where it was distributed

Distributed nationwide.

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: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

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

1. Firm started the recall: Jul 3, 202312. FDA classified it Class II: Aug 4, 202323. Published in FDA’s Enforcement Report: Aug 16, 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.

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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-2348-2023 (July 3, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2348-2023 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