The Recall Desk
ModerateFDA (Devices)·Z-1011-2018·Announced 2018-03-21

Zimmer Biomet Recalls Mislabelled Vanguard CR Porous Femoral Knee Implants

Zimmer Biomet is recalling eight Vanguard CR Porous Femoral knee implants because they are labeled as 62.5mm Left Femurs but contain 70mm Right Femurs.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The hazard is a labeling error (wrong size and side) rather than a material defect or contamination, fitting the Moderate severity criteria for labeling issues.

Plain-English summary

Zimmer Biomet, Inc. is recalling eight units of the Vanguard CR Porous Femoral 62.5mm (Left Femur) implant, intended for use in total knee arthroplasty. The recall is due to a labeling error where the product packaging identifies the contents as a 62.5mm Left Femur, but the actual implant inside is a Vanguard 70mm Right Femur.

The affected products are identified by Item #183066 and Lot 132900. The Universal Device Identifier (UDI) is (01) 0088030427068 (17) 270816 (10) 132900. These units were distributed in the United States to the states of Florida, Wisconsin, Maryland, Missouri, and Michigan.

Healthcare providers and patients should verify the specific size and laterality of the implanted device against the surgical records and the physical implant. If a device matching the description above has been implanted, providers should contact Zimmer Biomet for further instructions regarding the recall.

The recalled product

Product
Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty
Affected units
8

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Item #183066/Lot 132900
  • UDI-(01) 0088030427068 (17) 270816 (10) 132900

Distribution

Distributed in 5 states: