Biomet Vanguard Knee Implant Components Recalled for Incorrect Labeling

Plain-English summary

Biomet, Inc. is recalling specific Vanguard Knee System PS Open Box Femoral components intended for knee joint replacement. These components measure 57.5 mm, 60 mm, and 62.5 mm and are incorrectly labeled.

The labels on the components indicate either a different size or different side (left versus right) than the actual component. This discrepancy could lead to incorrect component selection during knee replacement surgery.

A total of 91 affected units were distributed internationally to Argentina, China, Costa Rica, India, Japan, Mexico, Netherlands, Ecuador, Republic of Korea, Singapore, and Thailand. In the United States, they were distributed to Florida, Indiana, Maryland, Ohio, Pennsylvania, and Wisconsin.

Patients and healthcare providers should contact Biomet, Inc. for information about this recall and any necessary replacement or verification procedures for their components.

The recalled product

Product

(1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement prostheses. Item Number: 183122 EXPANDED RECALL: (2) Vanguard Knee System PS Open Box Femoral; Left; 60 mm. Item Number: 183124 (3) Vanguard Knee System PS Open Box Femoral; Left;

Manufacturer

Biomet, Inc.

Category

Medical Device — Orthopedic Implant

Hazard

• mis-labeling
• surgical-implant-defect

Is your product affected?

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

Distribution

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