Drugs & medicalClass II

Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm…

Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique

Read the official notice →
Date
2024-07-24
Country
United States
Brand
Waldemar Link GmbH & Co. KG
Product
Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial…
Classification
Class II
Units
Nationwide Foreign: Algeria Argentina Australia Austria Belarus Belgium Brazil…
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 Details may be shortened or out of date; the official notice is the authoritative source.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

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  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. 2025-03-26
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    Waldemar Link GmbH & Co. KG (Mfg Site) recalls Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11

    A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.

    FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA,…Official notice →
  3. 2025-01-01
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    Waldemar Link GmbH & Co. KG (Mfg Site) recalls LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm,…

    Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).

    FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)US Nationwide distribution in the states of AL, FL.Official notice →
  5. 2024-10-02
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    Waldemar Link GmbH & Co. KG (Corp. Hq.) recalls LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01

    Some lots of the LINK Universal Handle, with quick coupling, Stainless Steel, straight may suffer an immediate material failure intraoperatively when the instrument is used for the first time. The instrument can break…

    FDA · DeviceWaldemar Link GmbH & Co. KG (Corp. Hq.)US Nationwide distribution in the states of FL, KS, MI, NJ, VA.Official notice →
  7. 2024-03-20
  8. US
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    Waldemar Link GmbH & Co. KG (Mfg Site) recalls SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented

    Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

    FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)US Nationwide distribution in the states of AL, AZ, CA, FL, GA, ID, IL, IN,…Official notice →
  9. 2024-03-13
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    Waldemar Link GmbH & Co. KG (Mfg Site) recalls Embrace Drill Tower, Wedged (25mm)

    The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.

    FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)US Nationwide distribution in the states of AL and LA.Official notice →
  11. 2024-03-06
  12. US
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    Waldemar Link GmbH & Co. KG (Mfg Site) recalls LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting…

    Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery

    FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Worldwide - US Nationwide distribution in the states of IL, IN, FL, WA and the…Official notice →
All 21 Waldemar Link GmbH & Co. KG recalls →

Other drugs & medical recalls in the United States

  1. 2024-07-31
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    Zydus Pharmaceuticals (USA) Inc recalls Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and…

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    FDA · DrugZydus Pharmaceuticals (USA) IncNationwide within the United StatesOfficial notice →
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  4. 2024-07-24
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    Alcon Research LLC recalls Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399

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    FDA · DeviceAlcon Research LLCWorldwide - US Nationwide distribution including in the states of AL, AR, CA,…Official notice →
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    Canadian Hospital Specialties Ltd. recalls Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic…

    A customer found product with incomplete seals of P/N 20400161S, lot #185198 which can lead to non-sterile product and patient safety concerns. CHS has validated this complaint.

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    Ethicon Sarl, a Johnson & Johnson Company recalls SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961

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See all drugs & medical recalls →