🔍 RecallPedia

Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total knee arthroplasty surgical procedure Item Number: 17-5220/01

Class I - Dangerous
🏥 Medical Devices Recalled: July 26, 2023 Waldemar Link GmbH & Co. KG (Mfg Site) Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 04026575284658 Lot Codes: C010108, C151519
  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:
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 prolongation of surgery or modified surgery
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total knee arthroplasty surgical procedure Item Number: 17-5220/01

Product Codes/Lot Numbers:

UDI-DI: 04026575284658 Lot Codes: C010108, C151519

Distribution:

Distributed in: IN, GA, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2481-2023

Related Recalls

Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;

Waldemar Link GmbH & Co. KG (Mfg Site)

Class I - Dangerous

The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.

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