Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Model/Catalog Number: 41888-04 Description: FEM&TIB CUT BLOCK ADP "UNIVERSAL" BASE1 Model/Catalog Number:41866-77A Description: FEM&TIB CUT BLOCK ADAPTER KIT UNIV Model/Catalog Number: 99700-43 Description: IGS INSTRUMENTATION UDI: GTIN 04056481002626 Serial numbers/lot numbers: - 1267114001 1267114070 - 1308615001 1308615045
  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:
Brainlab AG
Reason for Recall:
Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base with specific serial numbers might contain parts made from incorrect material and therefore not be suitable for reprocessing
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic

Product Codes/Lot Numbers:

Model/Catalog Number: 41888-04 Description: FEM&TIB CUT BLOCK ADP "UNIVERSAL" BASE1 Model/Catalog Number:41866-77A Description: FEM&TIB CUT BLOCK ADAPTER KIT UNIV Model/Catalog Number: 99700-43 Description: IGS INSTRUMENTATION UDI: GTIN 04056481002626 Serial numbers/lot numbers: - 1267114001 1267114070 - 1308615001 1308615045

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0959-2017

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