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High RiskFDAfda-Z-2154-2020OTHER

Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM; 184764 Knees Vanguard Knee System, Series-A Stand...

Units Affected
91
Recall Date
April 17, 2020
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2154-2020.

Potential presence of elevated endotoxin levels that exceed the specification limit

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2154-2020.

Recall terminated by FDA.

✅ What you should do

  1. Stop using the product if you own it.
  2. Check the model number, lot code, or sell-by date against the recall notice above.
  3. Contact Biomet, Inc. or the retailer where you bought it for a refund, replacement, or repair.
  4. For the most current official instructions, visit the FDA recall page.
  5. If you've been hurt by this product, report the incident to FDA.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2154-2020.

Biomet, Inc.

FDA

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📣 Report a food, supplement, or cosmetic problem to the FDA

If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.

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Biomet, Inc. Recall FAQ

Biomet, Inc. is the subject of a medical implants safety report: Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM; 184764 Knees Vanguard Knee System, Series-A Stand.... The notice was published on April 17, 2020 by the U.S. Food and Drug Administration (FDA). Approximately 91 units are potentially affected.