🔍 RecallPedia

LINK 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

Class I - Dangerous
🏥 Medical Devices Recalled: July 3, 2023 Waldemar Link GmbH & Co. KG (Mfg Site) Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 04026575182091 Lot Numbers: B923004 B932049 C005089 C211009
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Waldemar Link GmbH & Co. KG (Mfg Site)
Reason for Recall:
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 issue
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

LINK 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

Product Codes/Lot Numbers:

UDI-DI: 04026575182091 Lot Numbers: B923004 B932049 C005089 C211009

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2346-2023

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