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High RiskFDAfda-Z-1043-2023OTHER

(1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement prostheses. Item Number: 183122 EXPAND...

Units Affected
91
Recall Date
December 29, 2022
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1043-2023.

Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1043-2023.

Recall ongoing. Follow firm instructions.

✅ 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-1043-2023.

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: (1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement prostheses. Item Number: 183122 EXPAND.... The notice was published on December 29, 2022 by the U.S. Food and Drug Administration (FDA). Approximately 91 units are potentially affected.