Drugs & medicalClass II

Waldemar Link GmbH & Co. KG (Mfg Site) recalls LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting diseases,…

Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this…

Read the official notice →
Date
2023-08-16
Country
United States
Brand
Waldemar Link GmbH & Co. KG
Product
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting diseases, fractures or defects…
Classification
Class II
Units
US Nationwide distribution.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Waldemar Link GmbH & Co. KG recalls

  1. 2024-01-24
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    Waldemar Link GmbH & Co. KG (Mfg Site) recalls Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee…

    Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resected and not fit correctly leading to…

    FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)US Nationwide distribution in the state of NH.Official notice →
  3. 2023-10-04
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    Waldemar Link GmbH & Co. KG (Mfg Site) recalls MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees…

    Product is labeled with incorrect offset.

    FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Domestic distribution to AL, NJ, NV.Official notice →
  5. 2023-09-06
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    Waldemar Link GmbH & Co. KG (Mfg Site) recalls Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis…

    A crack in the weld of the rasp handle may lead to a fracture of the frontal sleeve when the rasp is further impacted or extracted. The rasp remains intact. The rasp would need to be pulled out by a clamp leading to a…

    FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)IN,GA, TXOfficial notice →
  7. 2023-07-12
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    Waldemar Link GmbH & Co. KG (Mfg Site) recalls LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and…

    Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).

    FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX.Official notice →
  9. 2023-07-05
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    Waldemar Link GmbH & Co. KG (Mfg Site) recalls LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left

    The firm discovered through customer complaints that device segments may not meet specifications.

    FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Domestic: AL, GA, IL, IN, KS, NJ, NY, and TX. Foreign: Argentina, Australia,…Official notice →
  11. 2022-07-20
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    Waldemar Link GmbH & Co. KG (Mfg Site) recalls Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817/35 Large, W 16-2817/37

    There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.

    FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Domestic distribution to AL, CA, FL, GA, IL, IN, KS, MI, MN, NV, NY, OH, TN,…Official notice →
All 21 Waldemar Link GmbH & Co. KG recalls →

Other drugs & medical recalls in the United States

  1. 2023-08-16
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    Randox Laboratories Ltd. recalls Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)

    Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in urea assays results if the urea assay is run immediately after…

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    Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.

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See all drugs & medical recalls →